MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1588 AIM CAMERA HEAD, C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	1588210105
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the visualization deteriorated and the case was converted to a open procedure.
Additional Manufacturer Narrative
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: visualization deteriorated.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, scope, light source, camera head , coupler, 1488 & 1588 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, manufacturing/ service nonconformity.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.H3 other text: 81.
Event or Problem Description
It was reported that the visualization deteriorated and the case was converted to a open procedure.

• Brand Name: PKG, 1588 AIM 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 17117715
• Report Number: 0002936485-2023-00584
• Device Sequence Number: 15211911
• Product Code: GCJ
• UDI-Device Identifier: 07613327174496
• UDI-Public: 07613327174496
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1588210105
• Device Catalogue Number: 1588210105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown