MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA ID TRACTIP; POWERED LASER SURGICAL INSTRUMENT

Model Number M006R8403960

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 06/25/2021

Event Type  malfunction  

Event Description

Flexiva id tractip high power single-use laser fiber was not working properly, and the hub where the fiber attaches to the surgical laser system was heating up.

• Brand Name: FLEXIVA ID TRACTIP
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12226573
• MDR Text Key: 263565907
• Report Number: 12226573
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M006R8403960
• Device Catalogue Number: M006R8403960
• Device Lot Number: 0000019045
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Weight: 112