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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 Circuit Failure (1089)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The asset shockpulse lithotripsy system was returned to the service center for evaluation.The evaluation found the power board was damaged with a fuse (f3) component detached.In addition, the suction warning label on top cover was damaged.The rest of other functions met standard specifications.The asset was last serviced/inspected on january 31, 2020.There were no problems identified and was returned to inventory.The cause of the reported power board failure could not be determined as the investigation is ongoing.However, if additional information becomes available this report will be supplemented accordingly.
 
Event Description
The service center became aware during a standard inspection, that the asset shock pulse lithotripsy system had a power board failure issue.There was no patient involvement reported.
 
Manufacturer Narrative
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
Type of Device
LITHOTRIPTOR, ULTRASONIC
Manufacturer (Section D)
GYRUS ACMI INC
136 turnpike road
southborough MA 01772
MDR Report Key10153292
MDR Text Key195136499
Report Number3011050570-2020-00011
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
Type of Report Initial,Followup
Report Date 07/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberSPL-S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2020
Was the Report Sent to FDA? No
Date Manufacturer Received06/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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