MAUDE Adverse Event Report: ARTHREX, INC. FUSED LIGHT CABLE; LIGHT, SURGICAL, FIBEROPTIC

Model Number	FUSED LIGHT CABLE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2022, it was reported by a sales representative via sems that a surgeon was holding a light cord as it melted through the surgeon's gown and partially into the lead vest underneath.This was discovered during a procedure.Additional information received on (b)(6) 2022: this was discovered during a left extracorporeal shockwave lithotripsy possible cystoscopy retrograde pyelogram on (b)(6) 2022.There was not harm to patient nor the surgeon, as the issue was noticed when the case was completed.
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.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
(no problem found) the evaluation found that the device performed as intended and complies with relevant standards.

• Brand Name: FUSED LIGHT CABLE
• Common Device Name: LIGHT, SURGICAL, FIBEROPTIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 14674378
• Report Number: 1220246-2022-05056
• Device Sequence Number: 17547202
• Product Code: FST
• UDI-Device Identifier: 00888867029408
• UDI-Public: 00888867029408
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K153218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2022

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 LIGHT CABLE
• Device Catalogue Number: AR-3240-5027
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 05/23/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown