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	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during knee arthroscopy procedure, the lens was overheating.It is unknown whether there was a back up available or delay in the case.No patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10: h3,h6: the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.The reported complaint of overheating could not be duplicated during the functional testing process.Ccu passed all functional testing and 4 hour burn-in inside of test tower.All video outputs and functions performed as expected.Surface temperature of product reached 40 degrees celsius during burn-in which is upper limit of specs for operational temp.The complaint of 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.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.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 found no related failures.

• 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 6512
• MDR Report Key: 9663174
• Report Number: 1643264-2020-00064
• Device Sequence Number: 3414569
• Product Code: GCJ
• UDI-Device Identifier: 00885556632000
• UDI-Public: 00885556632000
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/09/2020

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: 03/02/2020
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 02/03/2020
• Supplement Report FDA Received Date: 03/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1