MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SERVICE REPL LENS INT SYS WIFI VER; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72204354S
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Information (3190)
Date of Event	09/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the light of the lens integrated system could not turn on.It is unknown whether the event happened during surgery, and if there was a patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The reported device, intended for use in treatment, 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 it was observed the antenna was not returned and the equipot plug was loose.A functional evaluation revealed the light guide cable was recognized but the lamp does not turn on.The complaint was confirmed and the root cause was associated with 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.A complaint history review concluded this was a repeat issue.

• Brand Name: SERVICE REPL LENS INT SYS WIFI VER
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10611147
• Report Number: 1643264-2020-01360
• Device Sequence Number: 16895127
• Product Code: GCJ
• UDI-Device Identifier: 00885556632000
• UDI-Public: 00885556632000
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K153606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2020

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: 72204354S
• Device Catalogue Number: 72204354S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 11/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1