MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIVERSAL LIGHT GUIDE ORANGE 5MM X 8 FT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72204923
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a laparoscopic cholecystectomy procedure, after being connected to the source of lez for a few minutes, the image suddenly disappeared, they realized that the cable of the device was burned.Backup device was available to complete the procedure.No delay and 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
The device, which was used in a procedure, was returned for evaluation.The evaluation was performed by smith and nephew and could confirm the customer complaint for the cable of the device was burned.A visual inspection was performed and showed the light guide has been used in the field.Both ends of the light guide have three different colors of medical tape wrapped around the orange sheathing.The source end of the light guide shows the fibers are burnt.This damage occurred when the light guide was attached to the light source.A root cause could not be determined in confidence due to the severe burnt fibers.Possible root causes; excessive heat from the light source, a residue build up on the fibers, or broken fibers.A review of the manufacturing and complaint records was performed for the reported lot number, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.No manufacturing related defects were observed.No further investigation is required.

• Brand Name: UNIVERSAL LIGHT GUIDE ORANGE 5MM X 8 FT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 9449104
• Report Number: 3003604053-2019-00144
• Device Sequence Number: 19355256
• Product Code: GCJ
• UDI-Device Identifier: 00885556643723
• UDI-Public: 00885556643723
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K914919
• 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): 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 72204923
• Device Catalogue Number: 72204923
• Device Lot Number: 141220
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1