MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG 1288HD CAMERA CONTROL UNIT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	1288010000
Medical Device Problem Code	Smoking (1585)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a thermal event.
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.
Additional Manufacturer Narrative
Alleged failure: 1288 smoking in surgery room.It was plugged into a stryker cart.No camera head was plugged in.Did not look like damage to the cart plug.Update - no patient/user injuries.Device was warm to the touch.Heavy gray smoke.] the failure(s) identified in the investigation is consistent with the complaint record.Root cause: the root cause is an electrical component failure on the power supply board.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was a thermal event.

• Brand Name: PKG 1288HD CAMERA CONTROL UNIT
• 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: 15755297
• Report Number: 0002936485-2022-00639
• Device Sequence Number: 15033240
• Product Code: GCJ
• UDI-Device Identifier: 07613327063387
• UDI-Public: 07613327063387
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 01/27/2023

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: Other
• Device Model Number: 1288010000
• Device Catalogue Number: 1288010000
• 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: 10/25/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2011
• 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