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

Model Number	M0068404012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.(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
Note: this report pertains to the first of two accumax 200 laser fibers that were used in the same procedure.It was reported to boston scientific corporation on (b)(6) 2019 that two accumax 200 laser fibers were used during a procedure performed on an unknown date.According to the complainant, during the procedure, the first laser fiber was broken during usage.A second of the same device was used and the same issue occurred.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available; a supplement report will be submitted.
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2019 as no event date was reported.Problem code 1069 captures the reportable event of fiber broke.Investigation results: one accumax 200 laser fiber was returned broken in two pieces.The first piece measured approximately 159.8 cm from top of the connector to the break.The second piece measured approximately 157.5 cm from the break 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 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, likely a result of the fiber break occurring during use, resulting in a misfire.The condition of the returned device confirmed that the fiber was broken and the misfire was likely a result of the break occurring during used.Review and analysis of all available information indicated that the root cause is manufacturing deficiency.A complaint with a cause of manufacturing deficiency indicates that the problems were traced to the manufacturing process.An investigation was completed to address this issue which identified the most probable root cause of the fiber break as handling during the manufacturing process caused by the supplier manufacturer.A dhr (device history record) review was performed and the device met all manufacturing specifications.
Event or Problem Description
Note: this report pertains to the first of two accumax 200 laser fibers that were used in the same procedure.It was reported to boston scientific corporation on april 18, 2019 that two accumax 200 laser fibers were used during a procedure performed on an unknown date.According to the complainant, during the procedure, the first laser fiber was broken during usage.A second of the same device was used and the same issue occurred.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available; a supplement report will be submitted.

• 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
• MDR Report Key: 8605004
• Report Number: 3005099803-2019-02421
• Device Sequence Number: 2220272
• Product Code: GEX
• UDI-Device Identifier: 08714729784623
• UDI-Public: 08714729784623
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K093691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: 03/27/2022
• Device Model Number: M0068404012
• Device Catalogue Number: 840-401
• Device Lot Number: 0000007503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1