MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG SCOPIS ENT SOFTWARE WITH TGS 3.6; 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	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Per the customer the scans either will not load on the unit or will load the images backwards so that when the surgeon is operating on the patient left, the navigation/ct scan is showing that they are on the patient right.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Update: d9.Correction: follow-up report submitted to document the device was not available for evaluation.Update: h3 and h6.Device evaluation: follow-up report submitted to document the device log files were available and used to complete the investigation.
Event or Problem Description
Per the customer the scans either will not load on the unit or will load the images backwards so that when the surgeon is operating on the patient left, the navigation/ct scan is showing that they are on the patient right.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

• Brand Name: SCOPIS ENT SOFTWARE WITH TGS 3.6
• 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 18790429
• Report Number: 0008010177-2024-00015
• Device Sequence Number: 7702318
• Product Code: PGW
• UDI-Device Identifier: 07613327514179
• UDI-Public: 07613327514179
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161491
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8000-021-002
• Device Lot Number: VERSION 3.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 06/02/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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