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

Model Number	M0068403930
Medical Device Problem Codes	Melted (1385); Overheating of Device (1437); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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
This report pertains to the first of three devices that were used in the same procedure.Refer to manufacturer report number mfr.Report #3005099803-2020-04984 for the flexiva laser fiber, mfr report #3005099803-2020-04985 for the flexiva laser fiber and mfr report #3005099803-2020-04986 for the flexiva laser fiber.It was reported to boston scientific corporation on (b)(6) 2020 that a flexiva 550 laser fiber was used in a holmium laser enucleation of the prostate (holep) procedure performed on (b)(6) 2020.Reportedly, the laser unit used was a lumenis laser console.According to the complainant, during the procedure, it was noted that the laser fiber was beginning to melt inside the patient.A second and third of the same device was used and the same issue occurred.Reportedly, there was no burn injury to the user or to the patient.Due to the laser fiber failure the procedure was completed via open surgery, open prostatectomy.There were no additional patient complications reported as a result of this event.

• Brand Name: FLEXIVA
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10762997
• Report Number: 3005099803-2020-04984
• Device Sequence Number: 16978273
• Product Code: GEX
• UDI-Device Identifier: 08714729808206
• UDI-Public: 08714729808206
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2020

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 Expiration Date: 08/31/2023
• Device Model Number: M0068403930
• Device Catalogue Number: 840-393
• Device Lot Number: 0000009868
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/30/2020
• 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