ENDOFLATOR · recalls, adverse events, clearances

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.

42 linked reportsMalfunction 36Injury 6

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	0	1
2019-02	0	1
2019-04	0	4
2019-05	0	1
2019-06	0	1
2019-08	0	1.67
2019-09	0	5
2019-10	0	1
2019-11	0	1
2020-01	0	1
2020-02	0	2.67
2020-03	0	4.5
2020-04	0	6.67
2020-05	0	7
2020-06	0	11.5
2020-07	0	24
2020-08	0	16
2020-09	0	23.5
2020-10	0	14.25
2020-11	0	37
2020-12	0	40
2021-01	0	23
2021-02	0	16.25
2021-03	0	24
2021-04	0	28.67
2021-05	0	16.75
2021-06	0	23.5
2021-07	0	23.67
2021-08	0	42.5
2021-09	0	37
2021-10	0	34.5
2021-11	0	58.5
2021-12	0	38
2022-01	0	44.67
2022-02	0	48
2022-03	0	31.5
2022-04	0	32.5
2022-05	0	54.5
2022-06	0	22.2
2022-07	0	30
2022-08	0	61
2022-09	0	24.5
2022-10	0	15.33
2022-11	0	50
2022-12	0	13.33
2023-01	0	21.5
2023-02	0	43
2023-03	0	31.67
2023-04	0	22.5
2023-05	0	14.33
2023-06	0	66
2023-07	0	16
2023-08	0	22
2023-09	0	21.33
2023-10	0	27
2023-11	0	28.33
2023-12	0	27
2024-01	0	42.5
2024-02	0	49
2024-03	0	35.5
2024-04	0	19
2024-05	0	22.67
2024-06	0	31
2024-07	0	37.5
2024-08	0	84
2024-09	0	64
2024-10	0	41.25
2024-11	0	23.75
2024-12	0	17
2025-01	1	8
2025-02	2	6
2025-03	2	5.33
2025-04	2	3.25
2025-05	2	2.8
2025-06	2	4.6
2025-07	1	3.33
2025-08	2	7.4
2025-09	5	6.33
2025-10	0	15
2025-11	1	7.75
2025-12	2	5.33
2026-01	2	2.5
2026-02	2	3.83
2026-03	0	8
2026-04	5	4
2026-05	4	3.5
2026-06	7	4.33

This device (reports/month)Average device in FCX (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-06-24	9610617-2026-01453	Malfunction	—	exact di
2026-06-23	9610617-2026-01434	Malfunction	—	exact di
2026-06-23	9610617-2026-01442	Injury	Available	exact di
2026-06-23	2020550-2026-01442	Injury	Available	exact di
2026-06-15	9610617-2026-01374	Malfunction	Available	exact di
2026-06-11	9610617-2026-01360	Malfunction	Available	exact di
2026-06-01	9610617-2026-01245	Malfunction	Available	exact di
2026-05-21	9610617-2026-01148	Malfunction	Available	exact di
2026-05-18	9610617-2026-01128	Malfunction	Available	exact di
2026-05-15	9610617-2026-01115	Malfunction	Available	exact di
2026-05-06	9610617-2026-01020	Malfunction	Available	exact di
2026-04-29	9610617-2026-00981	Malfunction	Available	exact di
2026-04-23	9610617-2026-00912	Malfunction	Available	exact di
2026-04-20	9610617-2026-00866	Malfunction	Available	exact di
2026-04-15	9610617-2026-00844	Malfunction	Available	exact di

Showing 1–15 of 42

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2014-03-27	NAI	No action indicated	KARL STORZ GMBH & CO. KG	0
2010-10-21	NAI	No action indicated	KARL STORZ GMBH & CO. KG	0

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