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

Model Number	M006R8403931
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation results: one flexiva id 550 laser fiber was received for evaluation.Visual examination revealed that the exposed glass fiber tip measured approximately 1.5 mm and appeared used.Additional examination under magnification revealed that the pattern on the tip face was consistent with a fracture indicating that the tip detached.There was no damage along the body of the fiber and the fiber face within the sma connector.Functional analysis revealed that the ¿attach laser fiber¿ message cleared from the console after attachment, indicating that the fiber was recognized by the laser unit.The condition of the returned device does not confirm the event.Therefore, based on all gathered information, the reported issue was unable to be confirmed.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a flexiva id 550 laser fiber was used in a procedure performed on an unknown date.Reportedly, the laser unit used was a lumenis moses p120 console.According to the complainant, during the procedure and outside the patient, it was noted the laser fiber was not recognized by the laser unit.The procedure was completed with another flexiva id 550 laser fiber.There were no patient complications reported as a result of this event.The patient condition at the conclusion of the procedure was reported to be fine.This event has been deemed an mdr-reportable event based on investigation results which revealed that the fiber tip detached.

• Brand Name: FLEXIVA (TM) ID 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: 7645725
• Report Number: 3005099803-2018-02092
• Device Sequence Number: 1652360
• Product Code: GEX
• UDI-Device Identifier: 08714729963806
• UDI-Public: 08714729963806
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2018

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 Expiration Date: 01/12/2021
• Device Model Number: M006R8403931
• Device Lot Number: 0000005519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1