MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIVA (TM) ID TRACTIP HIGH POWER SINGLE-USE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	M006R8403961
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; 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 on february 10, 2021 that a flexiva id tractip 200 laser fiber was used in a laser lithotripsy procedure in the kidney performed on (b)(6) 2021.It was reported that the laser unit used was a lumenis pulse 100h laser console.It was reported, during the procedure, the nurse unscrewed the laser fiber and it was noted to be broken at the rubber or metal connection point.The nurse got a mild burn.The severity of the burn was minor/mild and was treated with a localized treatment.The procedure was completed with another flexiva id tractip 200 laser fiber.There were no patient complications reported as a result of this event.

• Brand Name: FLEXIVA (TM) ID TRACTIP HIGH POWER SINGLE-USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11420647
• Report Number: 3005099803-2021-00895
• Device Sequence Number: 14170479
• Product Code: GEX
• UDI-Device Identifier: 08714729963844
• UDI-Public: 08714729963844
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/05/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/23/2023
• Device Model Number: M006R8403961
• Device Catalogue Number: 69270
• Device Lot Number: 0000009983
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 03/05/2021
• Patient Sequence Number: 1