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

Model Number	M0068403921
Medical Device Problem Codes	Break (1069); Misfire (2532)
Health Effect - Clinical Codes	Burn(s) (1757); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(4) 2018 that a flexiva 365 laser fiber was used for an unknown procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the laser fiber broke and hurt the scrub nurse's hand.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 CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 8213270
• Report Number: 3005099803-2018-62312
• Device Sequence Number: 19399677
• Product Code: GEX
• UDI-Device Identifier: 08714729808190
• UDI-Public: 08714729808190
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2019

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: 08/29/2021
• Device Model Number: M0068403921
• Device Catalogue Number: 840-392
• Device Lot Number: 0000006545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 01/03/2019
• Patient Sequence Number: 1