MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVCE REPL 3RD EDITION 660IMS; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72200242S3E
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the screen would go black mid case.Event occurred during a knee surgery.No patient injury 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 display malfunction was not confirmed.Display/touchscreen performed as expected during 6 hour burn-in.Product did fail functional testing with video input/output failure.The 660 module would only select s-video inputs 1 and 2 and aux input.It would not select hd-sdi video input.Also when the s-video input was selected it would not capture any video stills or clips.Cause of video input and capture failure is a defective electronic component on the video capture card.Unit passed functional testing and all video inputs and outputs normal with a known good capture card installed.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 3RD EDITION 660IMS
• 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: 7484833
• Report Number: 1643264-2018-00335
• Device Sequence Number: 1949251
• Product Code: GCJ
• UDI-Device Identifier: 00885554030846
• UDI-Public: (01)00885554030846
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K060777
• 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): 05/25/2018

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: 72200242S3E
• Device Catalogue Number: 72200242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1