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

Model Number	M0068404010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).(b)(4).Investigation results.The returned accumax 200 laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece.The piece measured 304.9 cm from the end of the connector to the distal tip.The exposed glass tip measured 2 mm and appeared degraded.Examination under magnification confirmed the pattern on the tip was consistent with normal degradation.Functional analysis revealed that there was no light from the sma connector, indicating a fracture within the fiber connector.No other problems with the device were noted.The reported event was not confirmed.The fibers are consumable and intended to degrade with use.Although the reported complaint was not confirmed, the fiber connector fracture likely resulted in difficulty using the fiber.It is likely that procedural handling of the device during set-up or use contributed to the fracture within the fiber connector.A broken fiber within the connector of the device can result in insufficient aiming beam and low laser energy output, up to a complete 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 review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that an accumax 200 laser fiber was used in a flexible ureteroscopic holmium laser lithotripsy procedure in the ureter performed on (b)(6) 2021.The laser unit used was a holmium laser console.Prior to procedure, it was found that the laser fiber was fractured and there was no laser energy.The procedure was completed with another accumax 200 laser fiber.There were no patient complications reported as a result of this event.Additional information: this event has been deemed reportable based on the investigation finding that the laser fiber was broken within the connector.

• 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: 12594721
• Report Number: 3005099803-2021-05201
• Device Sequence Number: 4290516
• Product Code: GEX
• UDI-Device Identifier: 08714729784586
• UDI-Public: 08714729784586
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

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: 11/20/2022
• Device Model Number: M0068404010
• Device Catalogue Number: 840-401
• Device Lot Number: 0000008770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 70