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

Model Number	M006R8403960
Medical Device Problem Codes	Degraded (1153); Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The complainant indicated that the device is not available for return; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a flexiva id tractip 200 laser fiber was used during a ureteroscopy procedure on (b)(6) 2021 for kidney stone treatment.Reportedly, a p100 console was used with settings of 1 joule and 53 hertz.During the procedure the laser fiber began to dim and little energy was being emitted.The operator unscrewed the fiber and noticed the connector was very hot.Reportedly, the operator burned his finger on the fiber connector because it was so hot.He got a blister from it.The treatment for the burn injury is unknown.There were no patient complications reported as a result of this event.

• Brand Name: FLEXIVA ID TRACTIP
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12196334
• Report Number: 3005099803-2021-03471
• Device Sequence Number: 14313021
• Product Code: GEX
• UDI-Device Identifier: 08714729963837
• UDI-Public: 08714729963837
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K110685
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M006R8403960
• Device Catalogue Number: 69270
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other