MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for LIGHTTRAIL REUSABLE M0068F64630 69266 manufactured by Boston Scientific Corporation.
[185199645]
(b)(4). The returned lighttrail reusable 270um laser fiber was analyzed, and a visual evaluation noted that it was returned in one piece. The fiber measured approximately 309. 3 cm from the top of the connector to the tip. The exposed glass portion of the tip measured approximately 1 mm and appeared fractured. Examination under magnification confirmed the pattern on the tip was consistent with a fracture. The remainder of the tip was not returned. Visual examination revealed that light cannot travel well to the fiber face within the sma connector to illuminate it fully, indicating that the fiber was broken within the connector. It was likely that due to the fracture within the connector that the fiber would not fire during a procedure. Functional analysis revealed that when the fiber was connected to the auriga laser console, the attach fiber message disappeared indicating that the fiber was recognized by the console. The laser console displayed the message, applicator has been used 3 times. No other issues with the device were noted. The reported event was confirmed. Review and analysis of all available information indicated that the root cause is adverse event related to procedure. A complaint with a cause of adverse event related to procedure indicates that the adverse event occurred during the procedure and the device had no influence on event. A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing. A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Patient Sequence No: 1, Text Type: N, H10
[185199646]
It was reported to boston scientific corporation on january 4, 2020 that a lighttrail reusable 270um laser fiber was used in a lithotripsy procedure in the kidney performed on january 2, 2020. Reportedly, the laser unit used was an auriga xl 50 watt laser console. According to the complainant, during the procedure, upon pressing down the foot switch there was no laser energy from the laser fiber. The fiber did not release any laser beam although there was light. The procedure was completed with another lighttrail reusable 270um laser fiber. There were no patient complications reported as a result of this event. This event has been deemed a reportable event based on the investigation finding of the laser fiber broken within the connector and fiber tip detached.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3005099803-2020-01243 |
MDR Report Key | 9882490 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2020-03-26 |
Date of Report | 2020-03-26 |
Date of Event | 2020-01-02 |
Date Mfgr Received | 2020-03-11 |
Device Manufacturer Date | 2019-06-14 |
Date Added to Maude | 2020-03-26 |
Event Key | 0 |
Report Source Code | Manufacturer report |
Manufacturer Link | Y |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | CAROLE MORLEY |
Manufacturer Street | 300 BOSTON SCIENTIFIC WAY |
Manufacturer City | MARLBOROUGH MA 01752 |
Manufacturer Country | US |
Manufacturer Postal | 01752 |
Manufacturer Phone | 5086834015 |
Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
Manufacturer Street | MODEL FARM ROAD CORK |
Manufacturer City | CORK IRELAND |
Manufacturer Country | EI |
Manufacturer Postal Code | IRELAND |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | LIGHTTRAIL REUSABLE |
Generic Name | POWERED LASER SURGICAL INSTRUMENT |
Product Code | GEX |
Date Received | 2020-03-26 |
Returned To Mfg | 2020-03-06 |
Model Number | M0068F64630 |
Catalog Number | 69266 |
Lot Number | 0023953744 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BOSTON SCIENTIFIC CORPORATION |
Manufacturer Address | 300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US 01752 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2020-03-26 |