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

Model Number	M0068404042
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2018 as the event date was reported to be (b)(6) 2018.This event was reported to the fda via a voluntary medwatch report.The report number is (b)(4).Investigation results: one accumax laser fiber was returned in one piece with the tip detached.The fiber measured approximately 278.9 cm from the top of the connector to the tip.The exposed glass portion of the distal tip measured approximately 0.5 mm.The pattern on the tip face was consistent with a tip detachment.The condition of the returned device confirms that the fiber tip detached, likely as a result of handling during setup of the device as it interacted with a scope.Review and analysis of all available information indicated that the cause code for this event is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on event.
Event or Problem Description
Note: this manufacturer report pertains to the third of four accumax laser fibers that were used in the same procedure.It was reported to boston scientific corporation on (b)(6) 2018 that an accumax 1000 laser fiber was used during a transurethral resection of the prostate (turp) procedure performed on an unknown date.According to the complainant, during the procedure, the laser fiber did not last very long and had to be replaced within an unusually short timeframe.It was noted that the tip of the laser fiber was used up much faster than normal.A second, third, and fourth accumax 1000 laser fiber were opened and the same issue occurred.The procedure was completed with a fifth accumax 1000 laser fiber.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available; a supplement report will be submitted.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the fiber tip detached.

• 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: 8380426
• Report Number: 3005099803-2019-00812
• Device Sequence Number: 11484744
• Product Code: GEX
• UDI-Device Identifier: 08714729784616
• UDI-Public: 08714729784616
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2019

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: 11/13/2020
• Device Model Number: M0068404042
• Device Catalogue Number: 840-404
• Device Lot Number: 5308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 75