MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG 1788 4K INLINE CAMERA HEAD C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	1788710105
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the image was cut-off and that a replacement was used to complete the medical procedure.Therefore, there was partial image loss.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
Multiple attempts have been made to retrieve the device for evaluation, and it is yet to be received in-house.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: image cut-off probable root cause: - improper tolerances of ch/coupler optics (e.G.Helical slot ring) - error in prism centering process - error in alignment of coupler optics the reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the image was cut-off and that a replacement was used to complete the medical procedure.Therefore, there was partial image loss.
Additional Manufacturer Narrative
Alleged failure: camera cable not recognized and image cut-off.The failure(s) identified in the investigation is consistent with the complaint record.Root cause: a short in the cable is the cause of this issue.The cable has been upgraded to contain this issue in the future.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 was cut-off and that a replacement was used to complete the medical procedure.Therefore, there was partial image loss.

• Brand Name: PKG 1788 4K INLINE 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: 22595532
• Report Number: 0002936485-2025-00672
• Device Sequence Number: 9190583
• Product Code: GCJ
• UDI-Device Identifier: 07613327580082
• UDI-Public: 07613327580082
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2026

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: 1788710105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 09/30/2025; 01/28/2026
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 10/28/2025; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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