MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 1288 CCU WITH FIBER BOARD INTERNATIONAL KIT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	1288010001
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
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 there was loss of image.
Event or Problem Description
It was reported that there was loss of image.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The technical service report is attached (see comm log), and indicates: examination description: at the time of the visit, there was no evidence of a problem with the 1288 arthroscopy system's monitor screen flickering, but the charge nurse and me reported that the recording device shut down (turned off) during the procedure.Work performed: checked the disconnection of the wiring of the video route, checked the power connection and operation of each device, and checked the operation of the recording device (sony's hvo-3300mt).Results : no problems were found with the 1288 arthroscope system screen, but just to be safe, the amperage of each device plugged into the outlet on the endcart was checked.Checked the amperage value of each device plugged into the end-cart outlet, and plugged in each device again so that the capacity does not exceed, and then plugged in the over capacity separately.We then contacted sony to arrange for a replacement recorder.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, fan / insufficient cooling, software, camera head (sensor, sensor cable), coupler (dust on optics, scratched optics, broken / shifted lenses, focusing mechanism, endoclamp), extension cable, intermittence while using rf devices (ex: valleylab), problem toggling light source from camera head, connected monitors, leaking, manufacturing/ service nonconformity & use error.The failure mode will be monitored for future reoccurrence.

• Brand Name: 1288 CCU WITH FIBER BOARD INTERNATIONAL KIT
• 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: 15163239
• Report Number: 0002936485-2022-00448
• Device Sequence Number: 14922906
• Product Code: GCJ
• UDI-Device Identifier: 07613327063400
• UDI-Public: 07613327063400
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132785
• 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): 10/12/2022

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 Model Number: 1288010001
• Device Catalogue Number: 1288010001I
• 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: 07/29/2022
• Supplement Date Received by Manufacturer: 07/29/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 10/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2012
• 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