• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION GREENLIGHT MOXY FIBER OPTIC POWERED LASER SURGICAL INSTRUMENT Back to Search Results
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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGREENLIGHT MOXY FIBER OPTIC
Type of DevicePOWERED 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 Key10474974
MDR Text Key205473556
Report Number2937094-2020-00795
Device Sequence Number1
Product Code GEX
Combination Product (Y/N)N
PMA/PMN NumberK120870
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received08/31/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number0010-2400
Device Catalogue Number0010-2400
Device LOT Number0024344980
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/22/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/29/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-