Scopis ENT · 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.

33 linked reportsMalfunction 32Injury 1

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	2.75
2019-02	0	3
2019-03	0	4.67
2019-04	0	2.44
2019-05	0	22
2019-06	0	4.25
2019-07	0	6
2019-08	0	7
2019-09	0	2.2
2019-10	0	1.75
2019-11	0	1.25
2019-12	0	5
2020-01	0	1.5
2020-02	0	2.4
2020-03	0	6
2020-04	0	1.5
2020-05	0	2
2020-06	0	2.4
2020-07	0	3
2020-08	0	5
2020-09	0	1.33
2020-10	0	6
2020-11	0	1.5
2020-12	0	5
2021-01	0	3
2021-02	0	4.5
2021-03	0	8
2021-04	0	5.33
2021-05	0	10.5
2021-06	0	5
2021-07	0	6.67
2021-08	0	5.6
2021-09	0	3.2
2021-10	0	3
2021-11	0	3
2021-12	0	3.67
2022-01	0	2.5
2022-02	0	3.75
2022-03	0	4.5
2022-04	0	3
2022-05	0	4.5
2022-06	1	2.89
2022-07	0	3.75
2022-08	0	3
2022-09	0	2.33
2022-10	0	5.5
2022-11	2	5.2
2022-12	1	2.25
2023-01	0	4.83
2023-02	0	2.67
2023-03	2	3.11
2023-04	3	3.5
2023-05	2	5.17
2023-06	1	3
2023-07	0	3.5
2023-08	4	3.8
2023-09	0	2.89
2023-10	4	2.5
2023-11	3	2.89
2023-12	2	4.11
2024-01	0	2
2024-02	0	3.25
2024-03	1	2.7
2024-04	0	4.09
2024-05	1	2.73
2024-06	0	2.33
2024-07	1	3
2024-08	0	6.67
2024-09	0	2
2024-10	0	4.6
2024-11	0	4.83
2024-12	0	3.8
2025-01	1	1.92
2025-02	0	4.65
2025-03	0	3.43
2025-04	1	1.93
2025-05	0	5.67
2025-06	0	8.5
2025-07	1	1.75
2025-08	0	4
2025-09	0	3
2025-10	0	2.4
2025-11	0	4.5
2025-12	0	2
2026-01	1	2.1
2026-02	0	2.33
2026-03	0	6.5
2026-04	1	1.38
2026-05	0	3
2026-06	0	2

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-04-22	0008010177-2026-99006	Malfunction	Available	exact di
2026-01-23	0008010177-2026-99003	Malfunction	Available	exact di
2025-07-29	0008010177-2025-99003	Malfunction	Available	exact di
2025-04-21	0008010177-2025-00042	Malfunction	Available	exact di
2025-01-21	0008010177-2025-00007	Malfunction	Available	exact di
2024-07-24	0008010177-2024-00067	Malfunction	Available	exact di
2024-05-20	0008010177-2024-00046	Injury	Available	exact di
2024-03-20	0008010177-2024-00020	Malfunction	Available	exact di
2023-12-27	3015967359-2023-02659	Malfunction	Available	exact di
2023-12-15	3015967359-2023-02624	Malfunction	Available	exact di
2023-11-20	3015967359-2023-02490	Malfunction	Available	exact di
2023-11-06	3015967359-2023-02438	Malfunction	Available	exact di
2023-11-02	3015967359-2023-02430	Malfunction	Available	exact di
2023-10-19	3015967359-2023-02135	Malfunction	Available	exact di
2023-10-19	3015967359-2023-02133	Malfunction	Available	exact di

Showing 1–15 of 33

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility
2025-02-27	NAI	No action indicated	Stryker Leibinger GmbH & Co. KG
2017-07-27	NAI	No action indicated	Stryker Leibinger GmbH & Co. KG
2013-11-14	NAI	No action indicated	Stryker Leibinger GmbH & Co. KG

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