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

Catalog Number	1688210105
Medical Device Problem Codes	No Display/Image (1183); Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the monitor was flickering.However, the duration of full loss of image could not be confirmed.
Additional Manufacturer Narrative
This event was initially reported as a malfunction for loss of image due to the monitor flickering because the duration of full loss of image could not be confirmed.Upon additional information provided, this event is no longer reportable as it was confirmed that the flickering was observed on right side of the monitor and that there was no full loss of image.
Event or Problem Description
This event was initially reported as a malfunction for loss of image due to the monitor flickering because the duration of full loss of image could not be confirmed.Upon additional information provided, this event is no longer reportable as it was confirmed that the flickering was observed on right side of the monitor and that there was no full loss of image.

• Brand Name: PKG 1688 AIM 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 ; 4087542000
• MDR Report Key: 23660667
• Report Number: 0002936485-2025-00954
• Device Sequence Number: 9193427
• Product Code: GCJ
• UDI-Device Identifier: 07613327418989
• UDI-Public: 07613327418989
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K182160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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: 1688210105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2023
• 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