MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RFB CCU HIGH DEF 560P 2NDGEN; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72201919F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/25/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the color went grey then the device blacked out.There was a surgical delay greater than 30 minutes.The procedure was completed with a backup device with no patient injury reported.
Additional Manufacturer Narrative
The device was received for evaluation.There was a relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Ccu failed functional testing with no live video output.Cause of video output malfunction is a defective fan on the analog output pcb.The defective fan resulted in the video processor pcb overheating and live video output malfunction.The complaint was confirmed and a root cause has been associated with an electrical component failure.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.

• Brand Name: RFB CCU HIGH DEF 560P 2NDGEN
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107 6512
• MDR Report Key: 7881867
• Report Number: 1643264-2018-00718
• Device Sequence Number: 19348150
• Product Code: GCJ
• UDI-Device Identifier: 00885556572818
• UDI-Public: (01)00885556572818
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K070266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2018

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: 72201919F
• Device Catalogue Number: 72201919F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Initial Date Received by Manufacturer: 08/27/2018
• Supplement Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1