MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER; POWERED LASER SURGICAL INSTRUMENT

Model Number	M0068403940
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the device lot number.Therefore, the manufacture and expiration dates are unknown.It was reported that the device was not used past its expiry date.(b)(4).Mfg.Site name (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 1000 laser fiber was opened for use in procedure performed on an unknown date.According to the complainant, during unpacking and outside the patient, the laser fiber broke upon removal from the sealed package.The procedure was completed with another flexiva 1000 laser fiber.There were no reported patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.Attempts to obtain additional information regarding this event have been unsuccessful to date.Should additional relevant details become available; a supplement report will be submitted.

• Brand Name: FLEXIVA (TM) HIGH POWER SINGLE-USE LASER FIBER
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7399716
• Report Number: 3005099803-2018-00977
• Device Sequence Number: 13781653
• Product Code: GEX
• UDI-Device Identifier: 08714729808121
• UDI-Public: 08714729808121
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Type of Report: Initial
• Report Date (Section B): 03/19/2018

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 Model Number: M0068403940
• Device Catalogue Number: 840-394
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2018
• Initial Report FDA Received Date: 04/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1