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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GYRUS ACMI, INC SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB; LITHOTRIPTOR, ULTRASONIC
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GYRUS ACMI, INC SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB; LITHOTRIPTOR, ULTRASONIC Back to Search Results
Model Number SPL-SR
Device Problems Erratic or Intermittent Display (1182); Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 11/07/2020
Event Type  malfunction  
Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.Investigation is ongoing, if additional information becomes available this report will be supplemented accordingly.
 
Event Description
It was reported that during preparation for use the device exhibited intermittent error message system stay in footswitch detected mode message.There were no further details provided regarding the event.No patient involvement on this event reported.No user injury reported.
 
Manufacturer Narrative
This report is being supplemented to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.
 
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Brand Name
SHOCKPULSE-SE LITHOTRIPSY SYSTEM (REUSAB
Type of Device
LITHOTRIPTOR, ULTRASONIC
Manufacturer (Section D)
GYRUS ACMI, INC
136 turnpike road
southborough PA 01772
MDR Report Key11068256
MDR Text Key228074707
Report Number3011050570-2020-00194
Device Sequence Number1
Product Code FEO
Combination Product (y/n)N
PMA/PMN Number
K142428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSPL-SR
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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