MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUTRAC (TM) SINGLE-USE HOLMIUM LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068404112
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2020 as the exact date was not given, but it was reported that the procedure took place a week before (b)(6) 2020.(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 march 10, 2020 that an accutrac 200 laser fiber was opened for use for a ureteroscopy with laser lithotripsy procedure in the ureter performed on an unknown date.According to the complainant, during preparation, upon removing the fiber out of the coil it was noted that the tip was bent.The procedure was completed with another accutrac 200 laser fiber.There were no patient complications reported as a result of this event.

• Brand Name: ACCUTRAC (TM) SINGLE-USE HOLMIUM 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: 9907838
• Report Number: 3005099803-2020-01437
• Device Sequence Number: 18996355
• Product Code: GEX
• UDI-Device Identifier: 08714729802709
• UDI-Public: 08714729802709
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K110686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2020

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: 03/14/2021
• Device Model Number: M0068404112
• Device Catalogue Number: 840-411
• Device Lot Number: 0000005759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1