MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH LIGHTTRAIL SINGLE USE; POWERED LASER SURGICAL INSTRUMENT

Model Number	M006864500
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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).Investigation results: one lighttrail single use 230m laser fiber was received for evaluation.Visual analysis revealed that the exposed glass fiber tip measured approximately 2.0 mm.Additional examination under magnification revealed that the pattern on the fiber face was consistent with a fracture indicating that the tip or portion of the tip detached.Functional analysis revealed that after attaching the fiber, the fiber was recognized by the console.The console gave error code 1101 ¿ fiber may not be used anymore.Please connect new fiber, indicating that this single use fiber has been fired upon one time.The aiming beam was bright, clear and scattered.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.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a lighttrail single use 230m laser fiber was used in a procedure performed on an unknown date.According to the complainant, during the preparation and outside the patient, the laser fiber was not recognized by the laser unit.The procedure was completed with another lighttrail single use 230m laser fiber.Boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.

• Brand Name: LIGHTTRAIL SINGLE USE
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7695878
• Report Number: 3005099803-2018-02217
• Device Sequence Number: 18993976
• Product Code: GEX
• UDI-Device Identifier: 08714729894940
• UDI-Public: 08714729894940
• Combination Product (Y/N): N
• PMA/510(K) Number: K111475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2018

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: M006864500
• Device Catalogue Number: 6450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2018
• Initial Report FDA Received Date: 07/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1