MAUDE Adverse Event Report: ARTHREX, INC. FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0'); LIGHT, SURGICAL, FIBEROPTIC

Model Number FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0')

Device Problems Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017)

Patient Problem Burn, Thermal (2530)

Event Date 11/07/2018

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The facility has placed device back into their inventory and will not be returning the device for evaluation.The cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported by the sales rep that during a d&c hysteroscopy, after the final view of the vaginal canal the surgeon grabbed the junction between the light post and distal tip of light guide and burnt his finger.Additional information obtained 11/7/2018: the sales rep has reported that the facility confirmed they had run some tests with the reported light cord vs two other light cords and the facility concluded there was nothing functionally wrong with the cord itself.The reported the issue had been that the light source was not turned off when the scope wasn't in use, causing the post and light cord junction to heat up excessively.The facility did not want a replacement light cord as they have already placed this light cord back into their scope sets and will continue to use this item as normal.There were no pictures taken of the burn.The surgeon did not require treatment other than running his finger under cold water after the procedure was completed.The facility did not confirm what size the burn spot was.

Manufacturer Narrative

Complaint not confirmed.Per vendor evaluation: the cable had several broken fibers but is functioning as it should.The cable is working as it should and misuse by the customer caused the issue.The device¿s ifu contains details for cable heat warnings and handling instructions.

• Brand Name: FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0')
• Type of Device: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8083919
• MDR Text Key: 127611704
• Report Number: 1220246-2018-00756
• Device Sequence Number: 0
• Product Code: FST
• PMA/PMN Number: K901035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0')
• Device Catalogue Number: AR-3240-5027
• Device Lot Number: WO145235
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/07/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Other