MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG SCOPIS ENT SOFTWARE WITH TGS 3.6.1; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number	8000021002
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 6 events were reported for this quarter.Product return status: 5 devices had investigation types that have not yet been determined.1 device was received.Additional information: 6 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 6 events for the failure: incorrect measurement.6 events had no health consequences or impact.
Event or Problem Description
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Events occurred between april 1 ¿ june 30 2025.This report summarizes 6 events for the failure: incorrect measurement.- 5 events had no health consequences or impact.- 1 event had prolonged surgery.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Mfr report # 0008010177-2025-99008.Supplemental rationale.Corrected data: b5, h6, h11.6 previously reported events were included in this follow-up record.Product return status.2 devices were evaluated using data provided by the user or third party.4 devices were not available for evaluation.Evaluation findings (results/components).5 devices: no device problem found / part/component/sub-assembly term not applicable 1 device: no findings available / part/component/sub-assembly term not applicable.Product disposition.6 devices: product not received.

• Brand Name: SCOPIS ENT SOFTWARE WITH TGS 3.6.1
• Common Device Name: EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 22647405
• Report Number: 0008010177-2025-99008
• Device Sequence Number: 8632503
• Product Code: PGW
• UDI-Device Identifier: 07613327514179
• UDI-Public: 07613327514179
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 6
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 8000021002
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown