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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC. SOLTIVE PRO SUPERPULSED LASER SYSTEM; SOLTIVE LASER SYSTEM

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GYRUS ACMI, INC. SOLTIVE PRO SUPERPULSED LASER SYSTEM; SOLTIVE LASER SYSTEM Back to Search Results
Model Number TFL-SLS
Device Problems Break (1069); Sparking (2595)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/13/2024
Event Type  malfunction  
Event Description
It was reported, that the laser system had broke at the connector flexible part and sparked.The issue was found during the therapeutic urethroscopy with laser lithotripsy procedure which was completed with a similar device.There were no reports of patient harm.
 
Manufacturer Narrative
The device was returned and the evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
SOLTIVE PRO SUPERPULSED LASER SYSTEM
Type of Device
SOLTIVE LASER SYSTEM
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 Key18812568
MDR Text Key337181357
Report Number3011050570-2024-00087
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 User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/29/2024
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 Health Professional
Device Model NumberTFL-SLS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/13/2024
Initial Date FDA Received02/29/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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