MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG 1788 4K CAMERA HEAD WITH INTEGRATED COUPLER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	1788610122
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
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 camera head has been going in and out of connection and when it is bent a specific way, it loses connection.
Event or Problem Description
It was reported that the camera head has been going in and out of connection and when it is bent a specific way, it loses connection.
Additional Manufacturer Narrative
Alleged failure: it was reported that the camera head has been going in and out of connection and when bent a specific way, it loses connection.The failure(s) identified in the investigation is consistent with the complaint record.Root cause: the cable was the root cause of the issue.Failure mode is being monitored by the quality team.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PKG 1788 4K CAMERA HEAD WITH INTEGRATED COUPLER
• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21928866
• Report Number: 0002936485-2025-00395
• Device Sequence Number: 9021822
• Product Code: GCJ
• UDI-Device Identifier: 07613327580044
• UDI-Public: 07613327580044
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K230605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2025

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: 1788610122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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