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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENLIGHT MOXY FIBER OPTIC; POWERED LASER SURGICAL INSTRUMENT
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BOSTON SCIENTIFIC CORPORATION GREENLIGHT MOXY FIBER OPTIC; POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Model Number 0010-2400
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/04/2023
Event Type  malfunction  
Event Description
It was reported that, during a photo-selective vaporization of the prostate, the first fiber was rotating inside the metal sheath and no longer firing after 73,095 joules with 7 minutes and 52 seconds of fiber use.A second fiber was then selected to continue with the procedure.However, the fiber began backfiring after 92,258 joules and minutes of fiber use.There were no patient complications; however, the procedure was aborted after the second fiber.This is for 2nd fiber.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
 
Event Description
It was reported that, during a photo-selective vaporization of the prostate, the first fiber was rotating inside the metal sheath and no longer firing after 73,095 joules with 7 minutes and 52 seconds of fiber use.A second fiber was then selected to continue with the procedure.However, the fiber began backfiring after 92,258 joules and minutes of fiber use.There were no patient complications; however, the procedure was aborted after the second fiber.This is for 2nd fiber.This event is being reported for aborted/cancelled procedure with a patient under anesthesia or sedation status is unknown.
 
Manufacturer Narrative
Upon receipt at our quality assurance laboratory, the returned fiber underwent a thorough analysis.Visual analysis of the returned fiber identified that the glass cap was rotating independently of the metal cap, indicating a glue failure, therefore the allegation is confirmed.The metal cap exhibited debris adhesion on its surface, indicative of tissue contact.Functional testing with the hene (helium-neon) laser fixture did not identify breaks along the length of the fiber.The connector cone, segments, and tabs appeared in good condition and secured.The fiber connector passed the connector segment verification test.The control knob is attached and aligned with fiber and can rotate the fiber as designed.It is probable that the tissue adhesion found at the metal cap during analysis contributed to elevated temperatures near the laser beam output window.Continuously elevated temperatures can lead to fiber damages, including independent glass cap rotation due to glue failure.The device instructions for use (ifu) instructs the user to maintain a working distance of 2 mm between the tissue and fiber tip during use and to increased irrigation flow by means of a saline pressure bag (set to 250 mmhg - 300 mmhg) to further increase liquid cooling effect to reduce fiber tip damage.Based on analysis result, the interaction between the user and device caused or contributed to the observed fiber damage.
 
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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
MY   01752
Manufacturer Contact
farshad fahimi
4100 hamline avenue north
building c
saint paul, MN 55112
MDR Report Key18094615
MDR Text Key328159270
Report Number2124215-2023-62862
Device Sequence Number1
Product Code GEX
UDI-Device Identifier00878953005515
UDI-Public00878953005515
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K120870
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2023
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 Number0030783517
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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