MAUDE Adverse Event Report: ARTHREX INC. FUSED UNI LIGHT CABLE,3.5MMX 274CM,GR; LIGHT, SURGICAL, FIBEROPTIC

Catalog Number	AR-3240-3530
Health Effect - Clinical Codes	Injury (2348); No Code Available (3191)
Date of Event	09/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This is one of two submissions from the same event.The other one is (b)(4).The device was received and an evaluation was conducted.The complaint was confirmed.Device history record review revealed nothing relevant to this event.The evaluation revealed that the returned "hot light guides" have significant proximal end glass attack.The clad glass is missing and the polished fiber is significantly recessed.Significant thermal energy absorption has discolored the proximal end tip.Transmission is half of the older reference light guide to no output on the lot number wo132759 light guide.Inefficient transmission will induce more absorption to the surrounding metal making it hot to the touch.The cause of the event is undetermined.This is the first complaint of this type for this part/lot combination.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the light-transition cable gets heated to over 90°c (194°f) after 1-2 min on the side that is connected to the light source.At the same time a burned material smell was released by the device through the ventilation.The heating also appears with a new cable from the same article.The nurse touched and removed the wire and incurred a burn injury - small burn blister.

• Brand Name: FUSED UNI LIGHT CABLE,3.5MMX 274CM,GR
• Common Device Name: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6983249
• Report Number: 1220246-2017-00404
• Device Sequence Number: 648953
• Product Code: FST
• UDI-Device Identifier: 00888867100671
• UDI-Public: 00888867100671
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K901035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: AR-3240-3530
• Device Lot Number: WO132759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2017
• Initial Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other