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

Model Number	M006R8403910
Medical Device Problem Codes	Overheating of Device (1437); Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 devices that were used in the same procedure.Refer to manufacturer report number mfr.Report for the first flexiva id 200 laser fiber and mfr.Report #3005099803-2021-01885 for the second flexiva id 200 laser fiber laser.It was reported to boston scientific corporation on april 1, 2021 that a flexiva id 200 laser fiber was used in a ureteroscopy procedure in the kidney performed on (b)(6) 2021.The laser unit used was a lumenis 30h laser console.During the procedure, when the physician stepped on the foot pedal, there was no energy coming out from the laser fiber.The aiming beam did not show and a burning smell was noticed.Additionally, the fiber connector felt warm.Another flexiva id 200 laser fiber was opened and the same exact issue occurred.There was no burn injury to the user or to the patient.The procedure was completed with a third flexiva id 200 laser fiber.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a1005 captures the reportable event of fiber connector overheats.Block h10: investigation results the returned flexiva id 200 laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece.The fiber measured 317.3 cm from the end of the connector to the end of the exposed glass tip.The exposed glass measured 3 mm and appeared in good condition.The sma boot was damaged, likely due to overheating.Light from the sma connector was dim and distorted, indicating a fracture within the fiber connector.No other problems with the device were noted.The reported event was confirmed.The analysis of the returned device revealed that the light from the sma connector was dim and distorted, indicating a fracture within the connector.Additionally, damage to the sma boot was observed.It is likely that procedural handling of the fiber during setup or use contributed to the fiber connector fracture, resulting in the failure to fire and overheating.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
Note: this report pertains to the first of two devices that were used in the same procedure.Refer to manufacturer report number mfr.Report #3005099803-2021-01884 for the first flexiva id 200 laser fiber and mfr.Report #3005099803-2021-01885 for the second flexiva id 200 laser fiber laser.It was reported to boston scientific corporation on (b)(6), 2021 that a flexiva id 200 laser fiber was used in a ureteroscopy procedure in the kidney performed on (b)(6), 2021.The laser unit used was a lumenis 30h laser console.During the procedure, when the physician stepped on the foot pedal, there was no energy coming out from the laser fiber.The aiming beam did not show and a burning smell was noticed.Additionally, the fiber connector felt warm.Another flexiva id 200 laser fiber was opened and the same exact issue occurred.There was no burn injury to the user or to the patient.The procedure was completed with a third flexiva id 200 laser fiber.There were no patient complications reported as a result of this event.

• Brand Name: FLEXIVA ID
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11708087
• Report Number: 3005099803-2021-01884
• Device Sequence Number: 3018086
• Product Code: GEX
• UDI-Device Identifier: 08714729963752
• UDI-Public: 08714729963752
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K100078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 01/07/2024
• Device Model Number: M006R8403910
• Device Catalogue Number: 69269
• Device Lot Number: 0000010430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 04/01/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR