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

Model Number	M0068404010
Medical Device Problem Codes	Overheating of Device (1437); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(b)(4).The device has been received but an evaluation has not yet been performed; therefore, a failure analysis is not available.If there is any further relevant information received, a supplemental medwatch report will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a accumax laser fiber was used during a lithotripsy under ureteroscopic by holmium laser procedure performed on (b)(6) 2019.According to the complainant, during the procedure the fiber body became exothermic.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a accumax laser fiber was used during a lithotripsy under ureteroscopic by holmium laser procedure performed on (b)(6) 2019.According to the complainant, during the procedure the fiber body became exothermic.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6) hospital.Initial reporter address 1: (b)(6).Initial reporter state: (b)(6).Device code 1437 was selected to represent the reportable event of fiber body overheating.One accumax laser fiber was returned with the connector detached from the fiber body.Visual examination revealed that light cannot travel well to the fiber face within the sma connector to illuminate it fully, indicating that there was a fracture within the connector prior to laser energy passing through the device.It is likely that due to the fracture within the connector that the laser energy damaged the connector, causing the reported overheating issue and resulting in the detachment of the connector from the body of the fiber.The fiber measures approximately 294.1 cm from the top of the connector to the break.The remainder of the fiber, including the distal tip, was not returned.The condition of the returned device confirms that the connector overheated as well as the fiber connector was fractured and detached and the fiber was fractured.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 problem occurred during the procedure and the device had no influence on event.A dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.The dhr review confirms that the accepted 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; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 9362331
• Report Number: 3005099803-2019-05655
• Device Sequence Number: 19576365
• 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: 06/04/2022
• Device Model Number: M0068404010
• Device Catalogue Number: 840-401
• Device Lot Number: 0000007849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 11/22/2019
• 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: 78 YR
• Patient Weight: 76