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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
Device evaluation determined that the reported issue was confirmed.The device was found with frayed wires sticking out from the transducer, the cable is separating from the transducer.Based on evaluation findings the reported failure was confirmed.Probable cause could be due to handling and or maintenance issue.
 
Event Description
It was reported that the device was found with exposed wire towards the part of the transducer.The issue occurred during a reprocessing.There was no patient involvement on this event.No user injury reported.
 
Manufacturer Narrative
This supplemental report is to advise 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 Key11120425
MDR Text Key239662239
Report Number3011050570-2021-00003
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 03/01/2021
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 Manufacturer12/10/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received01/05/2021
Supplement Dates Manufacturer Received02/23/2021
Supplement Dates FDA Received03/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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