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

Model Number	M0068404010
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 cystoscopy procedure in the bladder performed on (b)(6) 2019.Reportedly, the laser unit used was a dornier 30 watt.According to the complainant, during the procedure, a burst of laser energy and light was noted upon pressing down the foot pedal and the laser stopped firing.The laser fiber was unplugged and plugged back in but it still did not work.The procedure was completed with another accumax 200 laser fiber.There were no serious injury nor adverse patient effects reported.The patient condition at the conclusion of the procedure was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation on february 5, 2019 that an accumax 200 laser fiber was used during a cystoscopy procedure in the bladder performed on (b)(6) 2019.Reportedly, the laser unit used was a dornier 30 watt.According to the complainant, during the procedure, a burst of laser energy and light was noted upon pressing down the foot pedal and the laser stopped firing.The laser fiber was unplugged and plugged back in but it still did not work.The procedure was completed with another accumax 200 laser fiber.There were no serious injury nor adverse patient effects reported.The patient condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
Block h6: problem code 2532 for the reported event of fiber misfired.Block h10: investigation results: one accumax 200 laser fiber was returned in one continuous piece.The piece measured approximately 319.1 cm from the top of the connector 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.There was no damage along the body of the fiber.Visual examination revealed that light cannot traveled to the fiber face within the sma connector to illuminate it indicating that the fiber was broken within the connector, likely as a result of handling during setup of the procedure.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.

• 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: 8371166
• Report Number: 3005099803-2019-00973
• Device Sequence Number: 16650202
• Product Code: GEX
• UDI-Device Identifier: 08714729784586
• UDI-Public: 08714729784586
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K093691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2019

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: 11/16/2021
• Device Model Number: M0068404010
• Device Catalogue Number: 840-401
• Device Lot Number: 0000006902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1