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.
Additional Manufacturer Narrative
An evaluation was performed by smith & nephew and could not confirm the customer complaint for there is fiber damage and unexplainable burning of the universal light guide, the screen colored yellow.A visual inspection was performed and showed no damage to both fiber ends of the light guide.No burning was observed.The orange sheathing shows to have several ink spots.The light guide was functionally tested and functioned as intended.When the light guide was attached to the scope it provided a clear sharp image on the monitor.No yellowing was observed.No manufacturing related defects were observed.

• 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: 7763581
• Report Number: 3003604053-2018-00126
• Device Sequence Number: 1012865
• 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,Followup
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1