MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG PRECISION AC COUPLER C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	0700020122
Medical Device Problem Codes	Poor Quality Image (1408); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
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 there was blurry image.
Event or Problem Description
It was reported that there was blurry image.
Additional Manufacturer Narrative
The device was received at the local service facility for investigation.The technical service report indicates: reported by the customer: fuzzy image.P/n: 0700410105i and 0700020122.S/n: (b)(6).Summary of evaluation: it was not able to replicate the fault.Camera head and the coupler have been inspected and tested by two technicians - no faults found.Camera head has been tested with other coupler - no faults found.Image from the camera head has been compared to workshop's one.No difference in images found.Tests: qip.Function test: passed all tests.Probable root cause: cables, connectors, digital board, power supply, filter / fuse, ac inlet board, main board, transition board, fiber board, intermittence between transition board and ch connector, software, camera head, coupler, extension cable, intermittence while using rf devices, problem toggling light source or from camera head, connected monitors, leaking, use error, poor grounding, electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge, or manufacturing/ service nonconformity.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG PRECISION AC COUPLER 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21379848
• Report Number: 0002936485-2025-00113
• Device Sequence Number: 8595848
• Product Code: GCJ
• UDI-Device Identifier: 07613327137361
• UDI-Public: 07613327137361
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K142603
• 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): 05/09/2025

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: 0700020122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2020
• 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