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

Model Number 72204922

Device Problems Thermal Decomposition of Device (1071); Image Display Error/Artifact (1304); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2018

Event Type  malfunction  

Event 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.

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
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: jim gonzales ; 7000 west william cannon drive; austin, TX 78735 ; 5123585706
• MDR Report Key: 7763581
• MDR Text Key: 116860866
• Report Number: 3003604053-2018-00126
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00885556643716
• UDI-Public: (01)00885556643716(10)134379
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K914919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1