MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC 0.4MM CORE FIBER 10MM TIP; LASER INSTRUMENT, SURGICAL, POWERED

Model Number	9735560
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a thermal therapy system being used for a neuro soft tissue ablation procedure.It was reported that intra-operatively, the system had a disposable fiber which did not get the expected behavior when a 70% laser test dose.The surgeon requested a new fiber.The procedure was completed using the original fiber used.This was a two fiber case.The first laser fiber was placed into the second laser catheter after the second fiber did not seem to work as expected.There was no reported impact to patient outcome.There was a reported delay to the procedure of less than one hour due to this issue.

• Brand Name: 0.4MM CORE FIBER 10MM TIP
• Common Device Name: LASER INSTRUMENT, SURGICAL, POWERED
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8201456
• Report Number: 1723170-2018-06475
• Device Sequence Number: 1259496
• Product Code: GEX
• UDI-Device Identifier: 00643169933385
• UDI-Public: 00643169933385
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K053087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2020
• Device Model Number: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0216269299
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 82