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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 Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
Additional information is not available for this event as yet.Event date is not known.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.Manufacture date is not known.Upon inspection, it was observed that the connector socket at front was shifted left and out of alignment out of alignment.This is attributed to inadvertent mishandling by the user as the connectors are push-pull type and need to be handled accordingly.
 
Event Description
As reported for this event, the device was sent in for a two-year annual inspection maintenance, wherein the connector socket was found to be out of alignment.There is no patient involvement.
 
Manufacturer Narrative
The device was previously sent in for evaluation, therefore a service history review will replace device history record review.On june 09, 2020, the unit was inspected and tested by olympus estimation team.No functional problem was found, only minor scratches on the housing were notes.Damage to the transducer receptacle (the connector socket on the front panel) is often incurred as a result of user error, often the user does not realize all connections are push/pull and instead the plug is twisted upon connection or removal.This action results in damage to the pins internal to the socket and may crack or damage the housing.On page 14 of the device ifu, the transducer receptacle is addressed, "connect the transducer to the generator by pressing the plug straight in.Caution do not twist or turn the plug." on page 20, " connect the transducer to the generator by aligning the key way of the transducer connector with the key way slot on the transducer receptacle on the front panel.Push straight in.Caution do not twist or turn the plug.".
 
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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 PA 01772
MDR Report Key10600295
MDR Text Key208971486
Report Number3011050570-2020-00089
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 other,user facility
Type of Report Initial,Followup
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
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 Manufacturer08/28/2020
Was the Report Sent to FDA? No
Date Manufacturer Received01/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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