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

Catalog Number	72201919F
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/06/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device powered off a couple of times during the case and the back of it got really hot.There was a backup device available to complete the procedure with no delay.No patient injuries reported.
Additional Manufacturer Narrative
The device was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection was performed on the product and no issue was observed.Complaint of intermittent power failure and overheating could not be reproduced.Product passed functional testing including power cycling during 6 hour burn-in.Control unit was tested at different power input voltage levels ranging from 90 to 220 volts.No power or signal loss occurred during 6 hour testing.All live video outputs (composite, s-video, hd-sdi, etc.) normal.All functions perform as expected.The complaint of intermittent power failure and overheating was not confirmed and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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: 8203085
• Report Number: 1643264-2018-01010
• Device Sequence Number: 1901099
• Product Code: GCJ
• UDI-Device Identifier: 00885556572818
• UDI-Public: 00885556572818
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/22/2019

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 Catalogue Number: 72201919F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 03/21/2019
• Initial Report FDA Received Date: 12/28/2018
• Supplement Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1