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

Model Number 9735560

Device Problem Material Fragmentation (1261)

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

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

The unique identifier was not known at the time of reporting.The core fiber was returned to the manufacture for evaluation.After visual/physical examination the reported issue was not confirmed.They were not able to locate the reported leaks.No failure was found.The manufacture date was not available at the time of reporting.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) surgery.It was reported that the laser catheter was leaking.The health care professional (hcp) noticed an anomaly in the imaging during the first ablation trajectory and they discovered the catheter was leaking.The hcp moved to the 2nd trajectory and changed to a different kit and the same issue occurred.The site was able to complete the ablation.The surgery was part of the slate study, no replacements needed.There was no delay to the procedure.No impact on patient outcome.

• Brand Name: VISUALASE
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12280303
• MDR Text Key: 265151810
• Report Number: 1723170-2021-02000
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/05/2021

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 Model Number: 9735560
• Device Catalogue Number: 9735560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2021
• Initial Date FDA Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 86