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

Model Number	M0068404030
Medical Device Problem Codes	Break (1069); 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	09/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: the returned accumax 550 laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece.The fiber measured approximately 278 cm from the top of the connector to the tip.The exposed glass tip measured approximately 2mm and appeared fractured.Examination under magnification confirmed that the pattern on the tip was consistent with a fracture.Visual examination revealed that light cannot travel well to the fiber face within the sma connector to illuminate it fully, indicating that the fiber was broken within the connector.It is likely that due to the fracture within the connector that the fiber would fail to fire.No other issues with the device were noted.The reported event was confirmed.The analysis of the returned device confirmed that the fiber was broken within the connection and that the tip was detached likely as a result of handling damage during setup that manifested during the procedure.Damage within the connector of the device can result in inability for the fiber to fire.Review and analysis of all available information indicated that the root cause is adverse event related to procedure.A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A product labeling review identified that the device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on september 23, 2019 that an accumax 550 laser fiber was used in a renal pelvis laser lithotripsy procedure for calculus in the pelvis performed on (b)(6) 2019.Reportedly the laser unit was a keyiren.According to the complainant, during the procedure, the indicator light of the laser fiber was not seen after it was connected to the laser unit.The procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed a reportable event based on the investigation finding of the laser fiber broken within the connector and fiber tip detached.

• Brand Name: ACCUMAX
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9945867
• Report Number: 3005099803-2020-01602
• Device Sequence Number: 16335213
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/09/2020

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: 10/31/2021
• Device Model Number: M0068404030
• Device Catalogue Number: 840-403
• Device Lot Number: 0000006814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 65