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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC. SHOCKPULSE-SE LITHOTRIPSY SYSTEM; LITHOTRIPTOR, ULTRASONIC
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GYRUS ACMI, INC. SHOCKPULSE-SE LITHOTRIPSY SYSTEM; LITHOTRIPTOR, ULTRASONIC Back to Search Results
Model Number SPL-S
Device Problem Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/08/2024
Event Type  malfunction  
Manufacturer Narrative
The subject device was received and the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when relevant additional information becomes available.
 
Event Description
It was report that the device port was melted.There was no patient impact, no harm reported due to the event.
 
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Brand Name
SHOCKPULSE-SE LITHOTRIPSY SYSTEM
Type of Device
LITHOTRIPTOR, ULTRASONIC
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 Key18673043
MDR Text Key336190425
Report Number3011050570-2024-10001
Device Sequence Number1
Product Code FEO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSPL-S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/09/2024
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 Reuse
Patient Sequence Number1
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