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

Model Number	M006R8403920
Medical Device Problem Codes	Degraded (1153); Overheating of Device (1437)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a flexiva id 365 laser fiber was used in a ureteroscopy with laser lithotripsy procedure in the ureter performed on (b)(6) 2018.Reportedly the laser unit used was a moses p120 watt console.According to the complainant, during the procedure, it was noted that the laser fiber was not emitting enough laser energy to break the calculi.The staff checked the fiber and found that the fiber connector was hot to touch.Reportedly, the staff was not burned.The procedure was completed with another flexiva id 365 laser fiber.There were no serious injury nor adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
H6: problem code 1437 captures the reportable event of fiber connector overheats.H10: investigation results: a flexiva id 365 laser fiber was returned in one piece.The fiber measured approximately 278.3 cm from the top of the connector to the tip.Visual examination revealed that the exposed glass fiber tip measured approximately 3.5 mm and appeared unused.Additional examination under magnification confirmed that the tip was unused.Visual examination revealed that light cannot travel to the fiber face within the sub miniature-a (sma) connector to illuminate it indicating that the fiber is broken within the connector, likely as a result of handling during setup of the procedure, resulting in the connector overheating and confirming the complaint.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.A review of the device history record (dhr) was performed; no anomalies were noted.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a flexiva id 365 laser fiber was used in a ureteroscopy with laser lithotripsy procedure in the ureter performed on (b)(6) 2018.Reportedly the laser unit used was a moses p120 watt console.According to the complainant, during the procedure, it was noted that the laser fiber was not emitting enough laser energy to break the calculi.The staff checked the fiber and found that the fiber connector was hot to touch.Reportedly, the staff was not burned.The procedure was completed with another flexiva id 365 laser fiber.There were no serious injury nor adverse patient effects 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: 8246900
• Report Number: 3005099803-2019-00066
• Device Sequence Number: 11161290
• Product Code: GEX
• UDI-Device Identifier: 08714729963776
• UDI-Public: 08714729963776
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2019

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: 07/31/2021
• Device Model Number: M006R8403920
• Device Catalogue Number: 69269
• Device Lot Number: 0000006401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 01/15/2019
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1