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

Model Number	M0068404010
Medical Device Problem Codes	Break (1069); Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: one accumax 200 single box laser fiber was returned in one piece.The piece measured approximately 313.9 cm from the top of the connector to the tip.The tip had detached at the end of the jacketing and no exposed glass portion remained.Examination under magnification revealed that the fiber tip was fractured with a portion detached.The remainder of the tip was not returned.Visual examination revealed that light cannot travel to the fiber face within the sma connector to illuminate it, this indicated that the fiber was 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 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.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 (b)(6) 2019 that an accumax 200 single laser fiber was opened for use for a soft ureteral management of upper ureteral stone procedure in the ureter performed on (b)(6) 2019.According to the complainant, during preparation, it was noted that there was no laser energy coming out from the laser fiber upon connecting to the laser unit.The procedure was completed with another accumax 200 single laser fiber.There was 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 laser fiber was broken within the sma connector and tip detached.

• 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: 8932309
• Report Number: 3005099803-2019-04272
• Device Sequence Number: 14004749
• Product Code: GEX
• UDI-Device Identifier: 08714729784586
• UDI-Public: 08714729784586
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093691
• 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): 08/26/2019

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: 05/25/2020
• Device Model Number: M0068404010
• Device Catalogue Number: 840-401
• Device Lot Number: C000004661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 62