MAUDE Adverse Event Report: MEDTRONIC XOMED INC. VISUALASE; LASER INSTRUMENT, SURGICAL, POWERED

Model Number 9735560

Device Problems Material Fragmentation (1261); Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2021

Event Type  malfunction  

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 Description

Medtronic received information regarding a thermal therapy system being used in a soft tissue ablation (neuro).It was reported that there were two issues that were discovered with the kit.The first issue was that the protective tube had a wavy form and markings in the bends.The second issue was the that the health care professional discovered a mark at 60 mm from the diffusion tip.The reported issue was found during the verification process.Troubleshooting was performed and the catheter was inspected and no damage was found.Light was applied to the fiber and there was no apparent diffusion at the 60 mm mark.As the marking was unknown it was decided to get a new kit to be on the safe side.This one also had this marking and had a different lot number so it was decided to proceed with the second fiber.There was less than an hour delay in the case.No impact on patient outcome.Additional information was received stating that the reported cause of the event is unknown.They received confirmation from senior laser ablation surgical consultant that the marking at 60mm was part of production.Specifically the mark is second fiber protection layer that ends.Inspection didn't show any damage to the catheter.The second one from a different lot will not be returned as there's nothing wrong with the fiber.

• Brand Name: VISUALASE
• Type of Device: LASER INSTRUMENT, SURGICAL, POWERED
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11806035
• MDR Text Key: 250047219
• Report Number: 1045254-2021-00236
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00763000218188
• UDI-Public: 00763000218188
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K053087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/11/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2023
• Device Model Number: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0221456724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2021
• Initial Date FDA Received: 05/11/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 90