MAUDE Adverse Event Report: SMITH & NEPHEW, INC. UNIVERSAL LIGHT GUIDE ORANGE 5MM X 12 FT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 72204925

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the "light guide orange (5mm x 12ft)" had a dark substance around the connection point.The customer discussed the instructions for use and confirmed they using correctly 270°, 4 minutes, 30 cool down.No case reported; therefore, there was no patient involvement.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H11: corrected data on d4/h4.

Manufacturer Narrative

H10, h2: additional information on d4.H3, h6: the reported device, intended for use in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.A visual inspection revealed corrosion on the bundle tip at the instrument end.No dark substance was observed.Analysis of the customer provided images revealed brown residue between the tubing and the ferrule of various light guides and debris.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review concluded this was a repeat issue.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods that may prevent future recurrence of the reported event.

• Brand Name: UNIVERSAL LIGHT GUIDE ORANGE 5MM X 12 FT
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 11096366
• MDR Text Key: 224589893
• Report Number: 3003604053-2020-00182
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00885556643747
• UDI-Public: 00885556643747
• Combination Product (y/n): N
• PMA/PMN Number: K914919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2020
• Device Model Number: 72204925
• Device Catalogue Number: 72204925
• Device Lot Number: 156750
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1