MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG, 1488 HD 3 CHIP CAMERA CONTROL UNIT (CCU); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	1488010000
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2020
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.
Additional Manufacturer Narrative
Alleged failure: during this procedure, a two 1000 ml ns bags were used with an iv pressure bag.When pumping up the pressure bag, the ns bags broke sending fluid spraying around the room.There was a loss of image.The camera box had power, but the display screen continued to blink and the box would not load correctly.We couldn't get it to work after that.The failure(s) identified in the investigation is consistent with the complaint record.Root cause: user error.A liquid spilled occurred at the customers facility damaging the boards in the ccu.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 loss of image.

• Brand Name: PKG, 1488 HD 3 CHIP CAMERA CONTROL UNIT (CCU)
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10224996
• Report Number: 0002936485-2020-00257
• Device Sequence Number: 2603472
• Product Code: GCJ
• UDI-Device Identifier: 07613327061024
• UDI-Public: 07613327061024
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 08/25/2020

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: 1488010000
• Device Catalogue Number: 1488010000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 07/02/2020
• Supplement Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1