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	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that an accumax laser fiber was used in a flexible ureteroscopy procedure for a lithiasis renal treatment in the kidney performed on (b)(6) 2022.The laser unit used was an ems 20 watts laser console.During procedure, the laser fiber was more sensitive to use and the fiber body broke twice.No fragments fell inside the patient.The procedure was completed with another accumax laser fiber.There were no patient complications reported as a result of this event.
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)(4) 2022 that an accumax laser fiber was used in a flexible ureteroscopy procedure for a lithiasis renal treatment in the kidney performed on (b)(4) 2022.The laser unit used was an ems 20 watts laser console.During procedure, the laser fiber was more sensitive to use and the fiber body broke twice.No fragments fell inside the patient.The procedure was completed with another accumax laser fiber.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device code a0401 captures the reportable event of fiber break.Block h10: investigation results the returned accumax laser fiber was analyzed, and a visual evaluation noted that the laser fiber was returned in one piece.The fiber piece measured 317 cm from the end of the connector towards the distal tip.There was no exposed glass tip present.When connected to the laser console, the aim beam was not visible.A functional evaluation revealed that there was no light present from the sma connector, indicating a fracture within the connector.No other problems with the device were noted.The reported event of the accumax laser fiber broke was confirmed.It is likely that procedural handling of the device during set-up or use contributed to the fiber body break.Review and analysis of all available information indicated that the most probable root cause 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.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14283234
• Report Number: 3005099803-2022-02423
• Device Sequence Number: 6714152
• 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): 06/27/2022

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: 09/30/2023
• Device Model Number: M0068404010
• Device Catalogue Number: 840-401
• Device Lot Number: 0000010020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2020
• 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
• Patient Sex: Unknown