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

Model Number	M0068404010
Medical Device Problem Codes	Degraded (1153); Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and 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
It was reported to boston scientific corporation on (b)(6) 2019 that an accumax 200 laser fiber was used during a flexible ureteroscopy (furs) with kidney stone procedure in the kidney performed on (b)(6) 2019.Reportedly, the laser unit used was a dornier medilas h20 laser console with laser settings of 6 watts.According to the complainant, during the procedure, the laser fiber was not giving enough laser energy after 10 minutes of use and the connector of the fiber was noted to be very hot.The procedure was completed with another accumax 200 laser fiber.There were no patient or user complications reported as a result of this event.The patient's condition after the procedure was reported to be good.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that an accumax 200 laser fiber was used during a flexible ureteroscopy (furs) with kidney stone procedure in the kidney performed on (b)(6) 2019.Reportedly, the laser unit used was a dornier medilas h20 laser console with laser settings of 6 watts.According to the complainant, during the procedure, the laser fiber was not giving enough laser energy after 10 minutes of use and the connector of the fiber was noted to be very hot.The procedure was completed with another accumax 200 laser fiber.There were no patient or user complications reported as a result of this event.The patient's condition after the procedure was reported to be good.
Additional Manufacturer Narrative
Block h6: problem code 1437 captures the reportable event of fiber connector overheats.Block h10: investigation results: one accumax 200 laser fiber was returned in one piece.The fiber measured approximately 312.8 cm from the top of the connector to the tip.Exposed glass portion of the distal tip measured approximately 3m mm and appeared degraded from normal use.Examination under magnification confirms the pattern of the tip was consistent with normal degradation.Visual examination revealed that light can travel completely to the fiber face within the sma connector to illuminate it, this indicated that the fiber was continuous within the connector.No issues were observed with the sma connector.The investigation concluded that the failure was due to procedural factors and the device had no influence on the event, therefore, the most probable cause of the event is adverse event related to procedure.A dhr (device history record) review was performed and the device met all manufacturing specifications.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.

• 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: 8663176
• Report Number: 3005099803-2019-02807
• Device Sequence Number: 2039580
• Product Code: GEX
• UDI-Device Identifier: 08714729784586
• UDI-Public: 08714729784586
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 07/02/2019

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: 02/20/2022
• Device Model Number: M0068404010
• Device Catalogue Number: 840-401
• Device Lot Number: 0000007332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1