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

Catalog Number	8000-021-002
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes 12 malfunction events in which the device reportedly had an incorrect measurement.- 12 events had patient involvement: no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events 12 events were reported for this quarter.Product return status 2 devices were evaluated using data provided by the user or a third party.10 device investigation types have not yet been determined.Additional information 12 devices were not labeled for single-use.12 devices were not reprocessed or reused.
Event or Problem Description
This report summarizes 12 malfunction events in which the device reportedly had an incorrect measurement.- 11 events had patient involvement; no patient impact.- 1 event led to a prolonged surgery.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: b5, h6, h11 12 previously reported events are included in this follow-up record.Product return status 3 devices were not available for evaluation.9 devices were evaluated using data provided by the user or a third party.

• 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: 20497730
• Report Number: 0008010177-2024-00113
• Device Sequence Number: 3519464
• 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: 12
• 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): 01/28/2025

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: 8000-021-002
• Device Lot Number: VMSR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 01/28/2025
• 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