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

Model Number	M0068404030
Medical Device Problem Codes	Break (1069); Degraded (1153)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: one accumax 550 single use laser fiber was returned in one piece.The fiber measured approximately 279.4 cm from the top of the connector and includes the entire distal tip.Visual examination revealed that the exposed glass fiber tip measured approximately 3.5 mm and appeared unused.Examination under magnification confirmed that the tip was unused.Visual examination revealed that light cannot travel to the fiber face within the sma connector to illuminate it, this indicated that the fiber is broken within the connector.It is likely that due to the fracture within the connector that the fiber would fail to fire, confirming the complaint.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 dhr (device history record) review was performed and the device met all manufacturing specifications.
Event or Problem Description
It was reported to boston scientific corporation on june 28, 2019 that an accumax 550 single use laser fiber was used in a flexible ureteroscopy procedure in the ureter performed on (b)(6) 2019.According to the complainant, during the procedure, the laser fiber did not fragment the stone.The procedure was completed with another accumax 550 single use laser fiber.There was no serious injury nor adverse patient effects as a result of this event.This event has been deemed an mdr-reportable event based on investigation results which revealed that the laser fiber was broken within 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: 8994669
• Report Number: 3005099803-2019-04523
• Device Sequence Number: 235374
• Product Code: GEX
• UDI-Device Identifier: 08714729784609
• UDI-Public: 08714729784609
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 09/11/2019

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: 07/07/2020
• Device Model Number: M0068404030
• Device Catalogue Number: 840-403
• Device Lot Number: C000004847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 57