MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL CAM CONTROL UNT HIGH DEF 560P; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72200559S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the there was no image through the device during the surgery.Procedure was completed with a back-up device.No patient injury reported.
Additional Manufacturer Narrative
Investigator determined that there was a relationship found between the returned device and the reported incident.Complaint of live video output failure was confirmed.Cause of failure was a seating problem with the video input pcb and the video output pcb.Unit passed functional testing after the video input and output pcbs were reseated.The complaint investigation has concluded that this unit has exceeded its recommended service life limit and has succumbed to expected wear and tear.A visual inspection was performed on the product and no issue was observed.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: SVCE REPL CAM CONTROL UNT HIGH DEF 560P
• 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: 7345758
• Report Number: 1643264-2018-00229
• Device Sequence Number: 48435
• Product Code: GCJ
• UDI-Device Identifier: 03596010609786
• UDI-Public: (01)03596010609786
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2018

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: 72200559S
• Device Catalogue Number: 72200559S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 03/16/2018
• Supplement Report FDA Received Date: 04/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1