MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIVERSAL LIGHT GUIDE ORANGE 4MM X 12 FT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	72204922
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that due to fiber damage and unexplainable burning of the universal light guide, the screen colored yellow.There was a delay greater than 30 minutes.No patient injury was reported.

• Brand Name: UNIVERSAL LIGHT GUIDE ORANGE 4MM X 12 FT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7763584
• Report Number: 3003604053-2018-00127
• Device Sequence Number: 13901547
• Product Code: GCJ
• UDI-Device Identifier: 00885556643716
• UDI-Public: (01)00885556643716(10)134379
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2018

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: 72204922
• Device Catalogue Number: 72204922
• Device Lot Number: 134379
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1