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

Model Number	M0068404012
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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) 2018 that an accumax laser fiber was used during a ureteroscopy procedure performed on (b)(6) 2018.According to the complainant, during procedure, the tip of the laser fiber was noted to be broken straight from the package.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
Investigation result: one flexiva 200 tractip laser fiber was returned broken into two pieces with the tip detached.The first piece measured approximately 95.1 cm from the top of the connector to the break.The second piece measured approximately 211.2 cm from the top of break to the tip.The distal tip was not returned.The pattern on the tip face is consistent with a tip detachment, likely as a result of handling during the procedure.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.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 review of the device history record (dhr) was performed and no deviations were found.
Event or Problem Description
It was reported to boston scientific corporation on october 2, 2018 that an accumax laser fiber was used during a ureteroscopy procedure performed on (b)(6) 2018.According to the complainant, during procedure, the tip of the laser fiber was noted to be broken straight from the package.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: 8010861
• Report Number: 3005099803-2018-61075
• Device Sequence Number: 165287
• Product Code: GEX
• UDI-Device Identifier: 08714729784623
• UDI-Public: 08714729784623
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2019

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: 08/06/2021
• Device Model Number: M0068404012
• Device Catalogue Number: 840-401
• Device Lot Number: 0000006432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 10/26/2018
• Supplement Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1