MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENLIGHT MOXY FIBER OPTIC; POWERED LASER SURGICAL INSTRUMENT

Model Number 0010-2400

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown.The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.Analysis of the device revealed the glass cap shows a circumferential fracture on the distal side of fiber/cap fusion zone at the bevel edge.The fiber proximal to fracture can rotate independently of outer flow tubing.The potential for forward firing may exist.There was severe devitrification at output window on the glass cap.The metal cap exhibits moderate charred detritus adhesion on surface.The outer flow tubing open end exhibits minor scratch marks and slight melting on the output window.Due to the observed glass cap distal fracture, an evaluation conclusion code of unintended user error caused or contributed to event was assigned to this investigation.The manufacturer previously completed testing that confirmed that the fiber met all design specifications and performed as intended when the fiber is used per the instruction for use (ifu) and the user maintains a 2mm working distance between the tissue and the fiber tip during use.Further analysis noted that when there is tissue adhesion through constant and heavy tissue contact, this can lead to continuously elevated temperature at the fiber tip near the laser beam output window.These factors were identified as a major cause of the noted circumferential fracture.The manufacturer was only able to replicate the observed defect when the fiber tip was buried in tissue or there was tissue adhesion on the fiber tip from constant and heavy tissue contact which is in contrast with the operating instructions, thus further supporting this observation was induced by thermal instability from tissue contact / adhesion.As a result of this further investigation, an update has been made to the ifu to include a recommendation to increase irrigation flow by means of a pressurized saline bag to further increase the liquid cooling effect and potentially reduce the observation previously mentioned in addition to following the existing operating instructions to maintain a 2mm working distance.

Event Description

It was reported that the fiber was returned for analysis without any reported allegation.Analysis identified the glass cap shows a circumferential fracture on the distal side of fiber/cap fusion zone at the bevel edge that could potentially lead to forward firing.There was no information to indicate any clinical consequence.

• Brand Name: GREENLIGHT MOXY FIBER OPTIC
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 150 baytech drive; san jose, CA 95134 ; 4089353452
• MDR Report Key: 10474974
• MDR Text Key: 205473556
• Report Number: 2937094-2020-00795
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 00878953005515
• UDI-Public: 00878953005515
• Combination Product (y/n): N
• PMA/PMN Number: K120870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: 0010-2400
• Device Catalogue Number: 0010-2400
• Device Lot Number: 0024344980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Date Manufacturer Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1