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

Model Number	M0068404022
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
Note: this manufacturer report pertains to one of two accumax 365 laser fibers used in the same procedure.It was reported to boston scientific corporation on (b)(6) 2019 that two accumax 365 laser fibers were used during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the tip of the laser fiber detached.Another accumax 365 laser fiber was used and the same issue occurred.The procedure was completed with a third accumax 365 laser fiber.There were no serious injury nor adverse patient effects reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
(b)(4) captures the reportable event of fiber tip detached.Investigation results: an accumax 365 laser fiber was returned in one piece with the tip detached.The fiber measured approximately 277.9 cm from the top of the connector to the break.The fiber was kinked near the distal tip, likely as a result of handling.The distal tip was not returned.The pattern on the tip face was consistent with a tip detachment.Visual inspection of the returned fiber noted burn marks on the fiber jacketing, likely a result of the fiber break occurring during use, resulting in a misfire.The condition of the returned device confirmed that the fiber tip detached.Review and analysis of all available information indicated that the damage to the device is likely a result of handling.Therefore the most probable root cause is adverse event related to procedure.A dhr (device history record) review was performed and the device met all manufacturing specifications.
Event or Problem Description
This manufacturer report pertains to one of two accumax 365 laser fibers used in the same procedure.It was reported to boston scientific corporation on february 20, 2019 that two accumax 365 laser fibers were used during a ureteroscopy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was noted that the tip of the laser fiber detached.Another accumax 365 laser fiber was used and the same issue occurred.The procedure was completed with a third accumax 365 laser fiber.There were no serious injury nor adverse patient effects reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.

• Brand Name: ACCUMAXTM 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: 8424407
• Report Number: 3005099803-2019-01233
• Device Sequence Number: 2227708
• Product Code: GEX
• UDI-Device Identifier: 08714729784630
• UDI-Public: 08714729784630
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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,Followup
• Report Date (Section B): 04/22/2019

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: 12/07/2021
• Device Model Number: M0068404022
• Device Catalogue Number: 840-402
• Device Lot Number: 6995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2019
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1