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

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2024

Event Type  malfunction  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 336539287
• Report Number: 0008010177-2024-00015
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161491
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 8000-021-002
• Device Lot Number: VERSION 3.6
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1