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

Model Number 1488010000

Device Problems No Display/Image (1183); Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/09/2020

Event Type  malfunction  

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 Description

It was reported that there was loss of image.

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 Description

It was reported that there was loss of image.

• Brand Name: PKG, 1488 HD 3 CHIP CAMERA CONTROL UNIT (CCU)
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 10224996
• MDR Text Key: 197826761
• Report Number: 0002936485-2020-00257
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 07613327061024
• UDI-Public: 07613327061024
• Combination Product (y/n): N
• PMA/PMN Number: K132785
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1