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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

14 linked reportsInjury 14
24572020-10: 1 reports for this device; peer average 1/device2022-12: 1 reports for this device; peer average 1/device2023-01: 3 reports for this device; peer average 3/device2023-04: 1 reports for this device; peer average 1/device2023-05: 1 reports for this device; peer average 1/device2023-06: 7 reports for this device; peer average 7/device101201040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-1011
2022-1211
2023-0133
2023-0411
2023-0511
2023-0677
This device (reports/month)Average device in EOX (reports/device/month)
Failure-mode summaryAI-generated

14 linked report narratives available — no AI summary generated yet.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2023-06-02Z-2282-2023Class IIOpen, ClassifiedCell Collection Device may be at increased risk of the sponge detaching from the string during removal of the device from the patient, which could lead to device fragments in patient, obstruction, airway obstruction, secondary intervention, secondary intervention (with the primary procedure), supraglottic airway obstruction, and aspiration.Distribution: Worldwide - US Nationwide distribution in the states of NY, MN, VA, WI and the countries of Canada, Netherlands, Poland, United Kingdom.6902code info di
Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2023-06-229681384-2023-00030InjuryAvailableexact di
2023-06-199681384-2023-00029InjuryAvailableexact di
2023-06-089681384-2023-00028InjuryAvailableexact di
2023-06-059681384-2023-00026InjuryAvailableexact di
2023-06-059681384-2023-00027InjuryAvailableexact di
2023-06-013004904811-2023-00007InjuryAvailableexact di
2023-06-013004904811-2023-00006InjuryAvailableexact di
2023-05-159681384-2023-00023InjuryAvailableexact di
2023-04-289681384-2023-00022InjuryAvailableexact di
2023-01-319681384-2023-00007InjuryAvailableexact di
2023-01-279681384-2023-00006InjuryAvailableexact di
2023-01-043004904811-2023-00001InjuryAvailableexact di
2022-12-219681384-2022-00052InjuryAvailableexact di
2020-10-063004904811-2020-00032InjuryAvailableexact di
Regulatory clearances
  • 510(k)K181020Substantially equivalent (SESE) · 2018-08-16clearance family

Predicate lineage

Cited as predicate by: K203450, K233142

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-07-16NAINo action indicatedCovidien LLC0
2025-07-16NAINo action indicatedCovidien LLC0
2024-11-21NAINo action indicatedCovidien, LP0
2024-11-21NAINo action indicatedCovidien, LP0
2022-11-18VAIVoluntary action indicatedCovidien LP1
2022-11-18VAIVoluntary action indicatedCovidien LP1
2022-09-08VAIVoluntary action indicatedCovidien0
2022-09-08VAIVoluntary action indicatedCovidien0
2022-04-28OAIOfficial action indicatedCovidien2
2022-04-28OAIOfficial action indicatedCovidien2
2020-02-28VAIVoluntary action indicatedCovidien, LP1
2020-02-28VAIVoluntary action indicatedCovidien, LP1
2018-09-19NAINo action indicatedCovidien0
2018-09-19NAINo action indicatedCovidien0
2017-09-22VAIVoluntary action indicatedCovidien, LLC2
2017-09-22VAIVoluntary action indicatedCovidien, LLC2
2017-08-09NAINo action indicatedCovidien0
2017-08-09NAINo action indicatedCovidien0
2016-10-31NAINo action indicatedCovidien0
2016-10-31NAINo action indicatedCovidien0
2012-06-14WLWarning LetterCovidien, LP—
2012-06-14WLWarning LetterCovidien, LP—
2011-10-04WLWarning LetterOridion Medical 1987 Ltd.—
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