MAUDE Adverse Event Report: Stryker Endoscopy-San Jose PKG 1688 Camera Control Unit CCU; Laparoscope, General & Plastic Surgery

Catalog Number	1688010000
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, the arthroscopic image was no longer displayed on the monitor.The arthroscopy camera system was restarted in an attempt to restore the image; however, only the arthroscopic image was not displayed.The procedure was changed from an arthroscopic technique to a semi-open technique, and the surgery was resumed.The surgery was completed.The surgery was interrupted for approximately 30 minutes due to a malfunction of the camera system.The event occurred while the patient was under general anesthesia.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.

• Brand Name: PKG 1688 Camera Control Unit CCU
• Common Device Name: Laparoscope, General & Plastic Surgery
• Manufacturer (Section D): Stryker Endoscopy-San Jose; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): Stryker Endoscopy-San Jose; 5900 optical court; san jose CA 95138
• Manufacturer Contact: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; +1(408)754-2000
• MDR Report Key: 50507656
• Report Number: 0002936485-2026-00766
• Device Sequence Number: 18499721
• Product Code: GCJ
• UDI-Device Identifier: 07613327420081
• UDI-Public: 07613327420081
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K240174
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 1688010000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/31/2026
• Initial Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2019
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown