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

Model Number	M006R8403910
Medical Device Problem Codes	Break (1069); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: approximated to (b)(6) 2020 based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number.Therefore, the manufacture date and expiration date are unknown.(b)(4).The complainant indicated that the device was 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 november 2, 2020 that a flexiva id 200 laser fiber was used in a ureteroscopy procedure in the kidney and ureter performed on an unknown date.Reportedly, the laser unit used was a lumenis p120 holmium laser.According to the complainant, during the procedure, the physician attempted to withdraw the laser fiber from the scope, but he noticed that the laser fiber was not coming out.The physician continued to remove the fiber and noticed a piece of the fiber had broken off.The fiber broke approximately 6 cm back from the tip of the fiber.Reportedly, it was noticed after the case that the scope was burned.The physician successfully used a basket to retrieve the laser fiber fragment that fell off inside the patient.The procedure was successfully completed.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith effort.

• 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: 10898056
• Report Number: 3005099803-2020-05715
• Device Sequence Number: 2758207
• Product Code: GEX
• UDI-Device Identifier: 08714729963752
• UDI-Public: 08714729963752
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Report Date (Section B): 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M006R8403910
• Device Catalogue Number: 69269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention