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	12/11/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the camera turns on and off by itself.No backup was readily available, despite contact with reporter it is unknown if procedure was completed with the same device or with a competitive one.No procedure delay or patient injuries were reported.
Additional Manufacturer Narrative
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 turning itself on and off could not be reproduced.Product passed functional testing during 6 hour burn-in with no signal or power loss.Video image remained constant throughout burn-in and ccu did not power up or down by itself during burn-in.All functions perform as expected.The complaint 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.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 7180666
• Report Number: 1219602-2018-00055
• Device Sequence Number: 1054764
• Product Code: GCJ
• UDI-Device Identifier: 00885556572818
• UDI-Public: (01)00885556572818
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K070266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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: 01/09/2018
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 03/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1