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

Model Number	M0068404010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
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 a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an accumax 200 laser fiber was used during a flexible coledoco lithotripsy procedure to treat gallstones, performed on (b)(6) 2021.During the procedure, when the laser fiber reached the distal end of the scope working channel, the distal part of the laser fiber broke.The physician retrieved the broken piece of the laser fiber.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
Block h6: medical device problem code a0401 captures the reportable event of fiber break.Block h10: product investigation results: the returned accumax 200 laser fiber was analyzed and a visual evaluation noted that the device was returned in one piece.A visual analysis noted that the fiber measured 314.4 cm from the end of the connector to the distal tip.The fiber body was fractured/kinked 73mm from the distal end.The exposed glass tip measured 2 mm and had normal degradation.A functional evaluation found that when connected to the laser console, the aim beam was visible at the fractured/kinked location.No other problems were found with the returned device.The reported event of fiber break was confirmed.Analysis of the returned device observed the fiber body was fractured.Additionally, the exposed glass tip had normal degradation.Based on all available information, it is likely that procedural handling of the device during set-up or use, including interaction with the working channel of the scope, contributed to the fiber body break.Therefore, the most probable cause assigned is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an accumax 200 laser fiber was used during a flexible coledocolithotripsy procedure to treat gallstones, performed on (b)(6) 2021.During the procedure, when the laser fiber reached the distal end of the scope working channel, the distal part of the laser fiber broke.The physician retrieved the broken piece of the laser fiber.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
• Manufacturer (Section G): COHERENT INCORPORATED; 5100 patrick henry drive; santa clara CA 95054
• Manufacturer Contact: morley carole ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12885160
• Report Number: 3005099803-2021-06210
• Device Sequence Number: 4982192
• Product Code: GEX
• UDI-Device Identifier: 08714729784586
• UDI-Public: 08714729784586
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K093691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2022

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: 02/25/2024
• Device Model Number: M0068404010
• Device Catalogue Number: 840-401
• Device Lot Number: 0000010666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 79 KG