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

Model Number	9735560
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
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 in a electrode and probe placement procedure.It was reported that  there was a water leak in the catheter inserted in the patient.The patient was fine and they did not suffer any damage.The site had water return all the time during the procedure.The probable cause of the reported issue was that the health care professional did not close the catheter channel properly when they did a pull back of the fiber, so part of the water came out and didn't return to the drainage bag.The manufacturer representative noticed that the flow going out of  the water bag was pretty high, and it wasn't the same flow that came into the drainage bag, so the rep told the hcp to stop the laser and go inside to check if there was any leak.They noticed liquid was coming out through the catheter due to the catheter not being properly closed after the pull back.The hcp was asked to close the catheter tighter and it was checked that no more liquid came out.There was no reported delay to the procedure.No impact on patient outcome.

• Brand Name: VISUALASE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 12239295
• Report Number: 1045254-2021-00406
• Device Sequence Number: 17060912
• Product Code: GEX
• UDI-Device Identifier: 00763000218188
• UDI-Public: 00763000218188
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K053087
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/28/2021

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: 02/09/2023
• Device Model Number: 9735560
• Device Catalogue Number: 9735560
• Device Lot Number: 0221669925
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR
• Patient Weight: 15