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

Model Number	M0068404010
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 october 28, 2019 that an accumax 200 laser fiber was used in a lithotripsy holmium laser under flexible ureteroscopic procedure in the ureter performed on (b)(6) 2019.According to the complainant, during the procedure, the fiber connector overheated and could not be used.Reportedly, there was no burn injury to the user.The procedure was completed with another accumax 200 laser fiber.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).One accumax 200 laser fiber was returned broken.The piece measured approximately 308 cm from the top of the connector to the break.The remainder of the fiber, including the distal tip, was not returned.Visual inspection of the returned fiber noted burn marks on the fiber jacketing, likely a result of the fiber break occurring during use, resulting in a misfire.Visual inspection did not result in any evidence of the reported overheating of the connector.Review and analysis of all available information indicated that the root cause is manufacturing deficiency.A complaint with a cause of manufacturing deficiency indicates that the problems were traced to the manufacturing process.An investigation was completed to address this issue which identified the most probable root cause of the fiber break as handling during the manufacturing process caused by the supplier manufacturer.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.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that an accumax 200 laser fiber was used in a lithotripsy holmium laser under flexible ureteroscopic procedure in the ureter performed on (b)(6) 2019.According to the complainant, during the procedure, the fiber connector overheated and could not be used.Reportedly, there was no burn injury to the user.The procedure was completed with another accumax 200 laser fiber.There were no patient complications reported as a result of this event.

• 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: 9347781
• Report Number: 3005099803-2019-05663
• Device Sequence Number: 19516642
• 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,Followup
• Report Date (Section B): 12/17/2019

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: 11/18/2019
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 72