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

Model Number	9735560
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age not available from the site.The catheter was returned to the manufacture for evaluation.After visual/physical examination the reported issue was confirmed.As reported, the fiber had been broken over and was no longer usable.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 in a soft tissue ablation (neuro).It was reported that the fiber snapped right at the bolt.It had a good return and flow throughout the catheter prior to discovering that the fiber was damaged.There was less than an hour delay in the procedure.No impact on patient outcome.

• Brand Name: VISUALASE
• Common Device Name: LASER INSTRUMENT, SURGICAL, POWERED
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 11214048
• Report Number: 1045254-2021-00035
• Device Sequence Number: 19725631
• Product Code: GEX
• UDI-Device Identifier: 00763000218188
• UDI-Public: 00763000218188
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 01/22/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2022
• Device Model Number: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0221113987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 120