MAUDE Adverse Event Report: MEDTRONIC XOMED INC. VISUALASE COOLED LASER APPLICATOR SYSTEM; 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	12/06/2018
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.It was reported that intra-operatively, the clear cap on the laser diffusing fiber (ldf) continued to turn instead of stopping.This was not noticed during fiber assembly by the scrub and was discovered by the surgeon when inserting the fiber into the catheter.The surgeon was satisfied with the attachment between the fiber and catheter, but noticed that it connected differently than the other cooling laser applicator system used for the other target.The procedure was completed with no delay.There was no reported impact to patient outcome.
Additional Manufacturer Narrative
Additional information: additional information received indicated the lot number previously provided was not accurate.The lot number, udi, and manufacture date remain unknown.The luer lock was returned to the manufacturer for analysis.Analysis found that the internal threads were worn down or missing not allowing the mating part to secure properly.Analysis found that the reported event was related to a mechanical issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VISUALASE COOLED LASER APPLICATOR SYSTEM
• Common Device Name: LASER INSTRUMENT, SURGICAL, POWERED
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8219170
• Report Number: 1045254-2019-00001
• Device Sequence Number: 276807
• Product Code: GEX
• UDI-Device Identifier: 00643169933385
• UDI-Public: 00643169933385
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 01/29/2019

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: 09/06/2020
• Device Model Number: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0216171141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 01/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 70