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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC. SHOCKPULSE LITHOTRIPSY TRANSDUCER.; LITHOTRIPTOR, ULTRASONIC
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GYRUS ACMI, INC. SHOCKPULSE LITHOTRIPSY TRANSDUCER.; LITHOTRIPTOR, ULTRASONIC Back to Search Results
Model Number SPL-T
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2024
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.
 
Event Description
It was reported the subject device "plastic shroud towards the proximal end of the transducer has a piece that broke off".The event found at reprocessing.There was no patient involvement in this reported event.No harm reported.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Please also see updates (correction from the initial mdr report ) in h6 ( g code component code) - updated from pressure transducer to transducer, and f code - updated from f26 to f27 (no patient involvement).The device was returned to olympus for evaluation and the customer's allegation was confirmed.Device evaluation in addition, noted that the plug was found with damages and could not be plugged into the generator.Minor scratches on the housing were noted.A device history review - dhr of the current product was conducted, and no issues were found.Olympus will continue to monitor field performance for this device.
 
Event Description
It was reported the subject device "plastic shroud towards the proximal end of the transducer has a piece that broke off".The event found at reprocessing.There was no patient involvement in this reported event.No harm reported.
 
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Brand Name
SHOCKPULSE LITHOTRIPSY TRANSDUCER.
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 Key18797648
MDR Text Key336443080
Report Number3011050570-2024-10016
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 User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/23/2024
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 NumberSPL-T
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2024
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/30/2024
Initial Date FDA Received02/28/2024
Supplement Dates Manufacturer Received03/26/2024
Supplement Dates FDA Received04/23/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2019
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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