MAUDE Adverse Event Report: ARTHREX, INC. FUSED LHT GD,WOLF,5MMX 406CM 13.4; LIGHT, SURGICAL, FIBEROPTIC

Model Number	FUSED LHT GD,WOLF,5MMX 406CM 13.4
Health Effect - Clinical Code	Burn, Thermal (2530)
Date of Event	07/31/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during an med procedure, the fused light guide, ar-3240-5040, overheated and burned the patient.The customer reported that the side where the scope connected to the guide, was hot.Additional information provided 8/13/2020: procedure occurred on (b)(6) 2020.There was no rep present.The burn was noticed after the case; no photos are available.The surgeon used a transparent film dressing from another manufacturer and the patient is currently under observation.

• Brand Name: FUSED LHT GD,WOLF,5MMX 406CM 13.4
• Common Device Name: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10441846
• Report Number: 1220246-2020-02076
• Device Sequence Number: 3974953
• Product Code: FST
• UDI-Device Identifier: 00888867029415
• UDI-Public: 00888867029415
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/24/2020

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 Model Number: FUSED LHT GD,WOLF,5MMX 406CM 13.4
• Device Catalogue Number: AR-3240-5040
• Device Lot Number: WO144733
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other