MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068404020
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device component code relates to device problem code for the reported event of fiber broke.(b)(4).The complainant indicated that the device has been 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
This manufacturer report pertains to one of two devices used in the same procedure.Refer to the associated manufacturer report 3005099803-2017-03366 for the other associated device information.It was reported to boston scientific corporation on (b)(6) 2017 that two accumax 365 laser fibers were opened for use in a procedure performed on (b)(6) 2017.According to the complainant, during preparation and outside the patient, the laser fiber broke when inserted into the scope.The procedure was completed with a different device.Boston scientific has been unable to obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.

• Brand Name: ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7017815
• Report Number: 3005099803-2017-03367
• Device Sequence Number: 685196
• Product Code: GEX
• UDI-Device Identifier: 08714729784593
• UDI-Public: 08714729784593
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K082928
• 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): 10/23/2017

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: 04/03/2020
• Device Model Number: M0068404020
• Device Catalogue Number: 840-402
• Device Lot Number: C000004457
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2017
• Initial Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1