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

Model Number	M0068403941
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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
A flexiva 1000 laser fiber was returned to boston scientific corporation on (b)(6) 2018 and examined on (b)(6) 2018.According to initial inspection of the returned laser fiber, the fiber tip was damaged.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.
Additional Manufacturer Narrative
One flexiva 1000 laser fiber was received for evaluation.Visual examination revealed that there was no exposed glass fiber tip remaining.Additional examination under magnification revealed that the pattern on the tip face was consistent with degradation.There was no damage to the fiber face within the sma connector.Functional analysis revealed that the aiming beam was bright, clear and scattered with effective transmission of 71.5%.Given the event description and condition of the returned device, there isn't enough information to determine a probable root cause.  a review of the device history record (dhr) was performed; no anomalies were noted.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
A flexiva 1000 laser fiber was returned to boston scientific corporation on (b)(6) 2018 and examined on (b)(6) 2018.According to initial inspection of the returned laser fiber, the fiber tip was damaged.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: 7569347
• Report Number: 3005099803-2018-01759
• Device Sequence Number: 19381586
• Product Code: GEX
• UDI-Device Identifier: 08714729808138
• UDI-Public: 08714729808138
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup
• Report Date (Section B): 05/10/2018

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: 12/18/2020
• Device Model Number: M0068403941
• Device Catalogue Number: 840-394
• Device Lot Number: 0000005447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Initial Date Received by Manufacturer: 05/10/2018
• Supplement Date Received by Manufacturer: 06/25/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 07/19/2018
• Patient Sequence Number: 1