MAUDE Adverse Event Report: Stryker Endoscopy-San Jose PKG 1788 4K CAMERA HEAD C-MOUNT; Laparoscope, General & Plastic Surgery

Catalog Number	1788210105
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the camera system's functions cannot be controlled via the camera head, or can only be controlled with a significant delay.This leads to delays in surgery.In addition, the camera head becomes very hot due to these delays.This is particularly noticeable during a longer surgery.Therefore, there was a thermal event.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.

• Brand Name: PKG 1788 4K CAMERA HEAD C-MOUNT
• 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: 50194205
• Report Number: 0002936485-2026-00588
• Device Sequence Number: 9998753
• Product Code: GCJ
• UDI-Device Identifier: 07613327580037
• UDI-Public: 07613327580037
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K230605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/10/2026

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: 1788210105
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2025
• 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