MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1488 HD 3-CHIP CAMERA HEAD WITH INTEGRATED COUPLER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	1488610122
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2020
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 the camera head was overheating during a procedure.
Additional Manufacturer Narrative
Alleged failure: camera got hot during case.The failure(s) identified in the investigation is consistent with the complaint record.Root cause: the cable has an internal short to ground causing the camera head to slightly over-heat intermittently.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 camera head was overheating during a procedure.

• Brand Name: PKG, 1488 HD 3-CHIP CAMERA HEAD WITH INTEGRATED COUPLER
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9777570
• Report Number: 0002936485-2020-00110
• Device Sequence Number: 596267
• Product Code: GCJ
• UDI-Device Identifier: 07613327061000
• UDI-Public: 07613327061000
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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: 1488610122
• Device Catalogue Number: 1488610122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1