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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC. 200 MICRON TFL SINGLE USE FIBER; POWERED LASER SURGICAL INSTRUMENT
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GYRUS ACMI, INC. 200 MICRON TFL SINGLE USE FIBER; POWERED LASER SURGICAL INSTRUMENT Back to Search Results
Model Number TFL-FBX200S
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2024
Event Type  malfunction  
Event Description
During the device evaluation, the single use fiber was broken at the strain relief with signs of burning on the fiber side of the break.There were no reports of patient involvement.
 
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
200 MICRON TFL SINGLE USE FIBER
Type of Device
POWERED LASER SURGICAL INSTRUMENT
Manufacturer (Section D)
GYRUS ACMI, INC.
9600 louisiana avenue north
brooklyn park MN 55445
Manufacturer (Section G)
GYRUS ACMI, INC.
9600 louisiana avenue north
brooklyn park MN 55445
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19148324
MDR Text Key341473602
Report Number3011050570-2024-00138
Device Sequence Number1
Product Code GEX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183647
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/19/2024
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
Device Operator Other
Device Model NumberTFL-FBX200S
Device Lot NumberKR365725
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/04/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/19/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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