MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068404022
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
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) 2022 that an accumaxtm single use holmium laser fiber was used in a cystoscopy, left retrograde pyelogram, left ureteroscopy, holmium laser ablation left stone with basket stone extraction, and left ureteral stent procedure performed on (b)(6) 2022.The laser unit used was a lumenis pulse 100 watt holmium laser with laser settings of 1.4 joules with a total of 5 kilojoules.During procedure, the laser fiber broke while in use.The procedure was completed with a different device.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: 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.Block h11: block e4 and g3: medwatch number is mw5108163.
Event or Problem Description
It was reported to boston scientific corporation on april 11, 2022 that an accumaxtm single use holmium laser fiber was used in a cystoscopy, left retrograde pyelogram, left ureteroscopy, holmium laser ablation left stone with basket stone extraction, and left ureteral stent procedure performed on (b)(6), 2022.The laser unit used was a lumenis pulse 100 watt holmium laser with laser settings of 1.4 joules with a total of 5 kilojoules.During procedure, the laser fiber broke while in use.The procedure was completed with a different device.There were no patient complications reported as a result of this event.

• Brand Name: ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER
• 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: 14287235
• Report Number: 3005099803-2022-02485
• Device Sequence Number: 5524006
• Product Code: GEX
• UDI-Device Identifier: 08714729784630
• UDI-Public: 08714729784630
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K082928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2022

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: 05/26/2024
• Device Model Number: M0068404022
• Device Catalogue Number: 840-402
• Device Lot Number: 0000011132
• Was Device Available for Evaluation?: No
• 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: 05/05/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 05/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• 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
• Patient Sex: Unknown