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

Model Number	M0068404010
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/29/2019
Type of Reportable Event	Serious Injury
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 in a ureteral lithotomy under flexible ureteroscopic procedure performed on (b)(6) 2019.According to the complainant, during procedure, the indicator light of the device turned off about ten minutes into the procedure.Upon examination, the physician found a fractured part of the fiber inside the patient's body.Reportedly, it was the tip of the fiber and it was withdrawn from the patient.The procedure was completed with another accumax 200 laser fiber.There was no serious injury nor adverse patient effects as a result of this event.There were no patient complications.
Event or Problem Description
It was reported to boston scientific corporation on may 5, 2019 that an accumax 200 laser fiber was used in a ureteral lithotomy under flexible ureteroscopic procedure performed on (b)(6) 2019.According to the complainant, during procedure, the indicator light of the device turned off about ten minutes into the procedure.Upon examination, the physician found a fractured part of the fiber inside the patient's body.Reportedly, it was the tip of the fiber and it was withdrawn from the patient.The procedure was completed with another accumax 200 laser fiber.There was no serious injury nor adverse patient effects as a result of this event.There were no patient complications.
Additional Manufacturer Narrative
Problem code 2907 captures the reportable event of fiber tip detached.Investigation results: one accumax 200 laser fiber was returned in one piece with tip detached.The piece measured approximately 316.8 cm from the top of the connector to the break.Exposed glass portion of the distal tip measured approximately 0.5 mm and was consistent with a fracture, likely as a result of handling during the setup of the procedure.Examination under magnification revealed that the fiber tip was fractured with a portion detached.Visual inspection of the returned fiber noted burn marks on the fiber jacketing closest to the tip fracture, likely a result of the tip break occurring during use, resulting in a misfire.The condition of the returned device confirms that the fiber tip was detached.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 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: 8650178
• Report Number: 3005099803-2019-02689
• Device Sequence Number: 3020615
• 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): 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/17/2020
• Device Model Number: M0068404010
• Device Catalogue Number: 840-401
• Device Lot Number: C000004631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Initial Date Received by Manufacturer: 05/05/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR
• Patient Weight: 142