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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: E.M.S. ELECTRO MEDICAL SYSTEMS S.A. LITHOCLAST LITHOTRIPTOR, ELECTRO-HYDRAULIC

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E.M.S. ELECTRO MEDICAL SYSTEMS S.A. LITHOCLAST LITHOTRIPTOR, ELECTRO-HYDRAULIC Back to Search Results
Model Number 840717
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/25/2020
Event Type  malfunction  
Event Description
The patient end of the lithoclast broke in half while in use.
 
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Brand NameLITHOCLAST
Type of DeviceLITHOTRIPTOR, ELECTRO-HYDRAULIC
Manufacturer (Section D)
E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
11886 greenville ave ste 120
dallas TX 75243
MDR Report Key10051497
MDR Text Key190774231
Report Number10051497
Device Sequence Number1
Product Code FFK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number840717
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/17/2020
Event Location Hospital
Date Report to Manufacturer05/13/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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