MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUMAX; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068404020
Medical Device Problem Codes	Break (1069); Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: visual examination revealed that the exposed glass fiber tip measured approximately 3.0 mm and appeared unused.Additional examination under magnification confirmed that the tip was unused.There was no damage along the body of the fiber.The investigator was unable to examine the fiber face within the sma connector because light was unable to travel to the fiber face to illuminate it; this indicated that the fiber was broken within the connector.The condition of the returned device would cause the device to fail to fire and cause a weak/no aiming beam thereby confirming the event.Therefore, a review and analysis of all available information indicated that the root cause 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.A review of the device history record (dhr) was performed and no deviations were found.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that an accumax 365 laser fiber was used during a left ureteroscopy with laser procedure in the ureter performed on (b)(6) 2018.Reportedly, the laser unit used was a holmium yag 100 watt console.According to the complainant, during the procedure, it was noted that there was no laser energy coming out from the laser fiber.The procedure was completed with another accumax 365 laser fiber.There were no serious injury nor adverse patient effects reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the fiber was broken within the sma connector.

• Brand Name: ACCUMAX
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8112788
• Report Number: 3005099803-2018-61618
• Device Sequence Number: 1616475
• Product Code: GEX
• UDI-Device Identifier: 08714729784593
• UDI-Public: 08714729784593
• Combination Product (Y/N): N
• PMA/510(K) Number: K082928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/28/2018

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: 02/12/2021
• Device Model Number: M0068404020
• Device Catalogue Number: 69116
• Device Lot Number: 0000005636
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 71