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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 Defective Device (2588)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
As stated, the device upon return and inspection found the snow cone was not able to lock into unit due to a damaged thread.Device is non repairable.Root cause of the issue likely attributed to user maintenance, and, or handling issue.
 
Event Description
It was reported that during device receipt inspection, the device was found with damage thread, and the snow cone not able to lock.There was no patient involvement on this event.No user injury reported.
 
Manufacturer Narrative
This supplemental report is being submitted 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 LITHOTRIPSY TRANSDUCER.
Type of Device
LITHOTRIPTOR, ULTRASONIC
Manufacturer (Section D)
GYRUS ACMI INC
136 turnpike road
southborough PA 01772
MDR Report Key10756957
MDR Text Key214149682
Report Number3011050570-2020-00132
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,user f
Type of Report Initial,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
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 Manufacturer08/13/2020
Was the Report Sent to FDA? No
Date Manufacturer Received12/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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