MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG 1688 AIM 4K AUTOCLAVABLE CAMERA HEAD C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	1688410105
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the image is shifted up on the camera.There was partial image loss when the image was cut off.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
Alleged failure: issue-the image is shifted up on both cameras.Update - there was partial image loss when the image was cut off.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Root cause: no problem found: the probable root cause of the issue reported could be the scope.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the image is shifted up on the camera.There was partial image loss when the image was cut off.

• Brand Name: PKG 1688 AIM 4K AUTOCLAVABLE 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 ; 4087542000
• MDR Report Key: 23204073
• Report Number: 0002936485-2025-00819
• Device Sequence Number: 9122530
• Product Code: GCJ
• UDI-Device Identifier: 07613327562545
• UDI-Public: 07613327562545
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K212511
• 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): 12/16/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1688410105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 10/02/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2024
• 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