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

Model Number	M006R8403940
Medical Device Problem Codes	Degraded (1153); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: the returned flexiva id 1000 laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece.The fiber measured approximately 283 cm from the top of the connector to the tip.The exposed glass tip measured approximately 0.5 mm.Examination under magnification confirmed that the pattern on the tip was fractured.It is likely that the handling of the device during advancement to the target anatomy resulted in the tip being fractured.This damage likely contributed to the low power during the procedure.No other issues with the device were noted.The reported event was confirmed.This damage likely contributed to the reported low power.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 labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2020 that a flexiva id 1000 laser fiber was used in a bladder stone procedure in the bladder performed on (b)(6) 2020.Reportedly, the laser unit used was a lumenis 100 watt laser console.According to the complainant, during the procedure, when the physician stepped on the foot pedal of the laser unit, there was very little energy coming out from the fiber.The procedure was completed with another flexiva id 1000 laser fiber.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of the laser fiber tip detached.

• 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: 10139034
• Report Number: 3005099803-2020-02241
• Device Sequence Number: 11212719
• Product Code: GEX
• UDI-Device Identifier: 08714729963813
• UDI-Public: 08714729963813
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K100078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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: 02/20/2023
• Device Model Number: M006R8403940
• Device Catalogue Number: 69269
• Device Lot Number: 0000009178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1