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

Model Number	M0068404030
Medical Device Problem Codes	Failure to Fire (2610); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: the fiber was returned in one piece with the tip detached.The piece measured approximately 261.8 cm from the top of the connector to the tip.Exposed glass portion of the distal tip measured approximately 1.5 mm and is consistent with a fracture.The remainder of the distal tip was not returned.The pattern on the tip face is consistent with a tip detachment, likely as a result of handling.Functional analysis reveals that when the fiber was connected to the lumenis laser console, the "attach fiber" message disappeared indicating that the fiber was recognized by the console.The aiming beam exiting the distal tip was bright, clear, and round.Effective transmission was not measured due to the condition of the returned device.Review and analysis of all available information indicated that the root cause is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on event.Dhr (device history record) review was performed and did not identify evidence of deviations or non-conformances in the manufacturing processes that could contribute to the complaint.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that an accumax 550 laser fiber was used for an f-urs procedure in the ureter performed on (b)(6) 2018.According to the complainant, prior to the procedure, the laser fiber had no energy output when it was connected during the procedure.The procedure was completed with another accumax 550 laser fiber.There were no patient complications reported as a result of this event.This event has been deemed reportable based on the investigation results; fiber tip detached.

• Brand Name: ACCUMAX
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 8374001
• Report Number: 3005099803-2019-00986
• Device Sequence Number: 2138517
• Product Code: GEX
• UDI-Device Identifier: 08714729784609
• UDI-Public: 08714729784609
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082928
• 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
• Report Date (Section B): 02/27/2019

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: 07/07/2020
• Device Model Number: M0068404030
• Device Catalogue Number: 840-403
• Device Lot Number: C000004847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 68