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

Catalog Number	72204685S
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee procedure, there was no signal from the dvi port of the lens integrated system.The procedure was successfully completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was received for evaluation.A visual inspection was performed on the product and no issue was observed.There was a relationship found between the returned device and the reported incident.Ccu failed functional testing with blank dvi video output.Cause of output malfunction is a defective electronic component on the dsp module pcb.Product passed functional testing with a known good dsp pcb installed.The complaint was confirmed and the root cause has been determined to be a defective electronic component.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 isolated event.

• Brand Name: SERVICE REPL LENS INT SYS NON-WIFI VER
• Common Device Name: ESOPHAGOSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 10411947
• Report Number: 1643264-2020-00860
• Device Sequence Number: 3273706
• Product Code: GCL
• UDI-Device Identifier: 00885556632024
• UDI-Public: 885556632024
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K153606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

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 Catalogue Number: 72204685S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 09/11/2020
• Initial Report FDA Received Date: 08/16/2020
• Supplement Report FDA Received Date: 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1