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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.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2015-05-18Z-1727-2015Class IITerminatedDesign of device may expose user to injury to fingers or body partsDistribution: Distributed in the states of CA, IL, NC, and NY.5 unitsclearance family
Regulatory clearances
  • 510(k)K141523Substantially equivalent (SESE) · 2014-11-25clearance family

Predicate lineage

Cited as predicate by: K153092, K223064

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
2024-02-01VAIVoluntary action indicatedCooperSurgical, Inc.0
2023-05-16NAINo action indicatedCooperSurgical, Inc.0
2023-05-16NAINo action indicatedCooperSurgical, Inc.0
2023-04-27VAIVoluntary action indicatedLone Star Medical Products, Inc.5
2022-12-15NAINo action indicatedLeisegang Feinmechanick-Optik GmbH0
2021-07-15VAIVoluntary action indicatedCooperSurgical, Inc.4
2021-07-15VAIVoluntary action indicatedCooperSurgical, Inc.4
2019-08-01NAINo action indicatedCooperSurgical, Inc.2
2018-05-02NAINo action indicatedLone Star Medical Products, Inc.0
2017-12-07NAINo action indicatedCooperSurgical, Inc.0
2017-12-07NAINo action indicatedCooperSurgical, Inc.0
2017-05-04NAINo action indicatedLone Star Medical Products, Inc.0
2016-03-31NAINo action indicatedCooperSurgical, Inc.0
2016-03-31NAINo action indicatedCooperSurgical, Inc.0
2015-12-10NAINo action indicatedLeisegang Feinmechanick-Optik GmbH0
2015-06-09WLWarning LetterCooperSurgical, Inc.—
2015-06-09WLWarning LetterCooperSurgical, Inc.—
2014-12-17OAIOfficial action indicatedCooperSurgical, Inc.8
2014-12-17OAIOfficial action indicatedCooperSurgical, Inc.8
2014-12-01NAINo action indicatedCooperSurgical, Inc.0
2014-12-01NAINo action indicatedCooperSurgical, Inc.0
2014-09-23VAIVoluntary action indicatedLone Star Medical Products, Inc.0
2013-04-25WLWarning LetterLone Star Medical Products, Inc.—
2012-07-11WLWarning LetterLeisegang Feinmechanick-Optik GmbH—
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