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

Model Number	M0068403930
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Optical Problem (3001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2018
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
It was reported to boston scientific corporation on november 6, 2018 that a flexiva 550 laser fiber was used in a laser stone case procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the aiming beam was undetectable and the tip of the laser fiber was noted to be missing.The tip was undetectable under xray.There were no 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: 9752046
• Report Number: 3005099803-2020-00393
• Device Sequence Number: 19190396
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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: 05/15/2020
• Device Model Number: M0068403930
• Device Catalogue Number: 840-393
• Device Lot Number: C000004618
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2018
• Initial Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1