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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STORZ MEDICAL AG MODULITH SLX-F2 TRANSPORTABLE LITHOTRIPTOR
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STORZ MEDICAL AG MODULITH SLX-F2 TRANSPORTABLE LITHOTRIPTOR Back to Search Results
Model Number 11000F2
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Hematoma (1884)
Date of Event 01/26/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The lithtriptor was inspected at the facility by our technician.The technician found nothing wrong with the system; all measured values were found within oem specifications.Additionally, the customer advised that there were no karl storz lithotripsy system error's or issues during the case.Hematomas are a known side effect of lithotripsy, which is addressed in our ifu.
 
Event or Problem Description
Allegedly, the patient presented with a recto-peritoneal bleed the day after a left extracorporeal shock wave lithotripsy procedure.The patient was admitted and was hospitalized for 8 days.We have not been able to obtain any further details about this event or patient condition.
 
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Brand Name
MODULITH SLX-F2 TRANSPORTABLE LITHOTRIPTOR
Common Device Name
LITHOTRIPTOR
Manufacturer (Section D)
STORZ MEDICAL AG
untereseestrasse 47
kreuzlingen ch-8280,
SZ 
MDR Report Key8515172
Report Number9613347-2019-00036
Device Sequence Number1942031
Product Code LNS
UDI-Device Identifier07630039100230
UDI-Public7630039100230
Combination Product (Y/N)N
PMA/510(K) Number
K040476
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Type of Report Initial
Report Date (Section B) 03/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number11000F2
Device Catalogue Number11000F2
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/19/2019
Initial Report FDA Received Date04/15/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
Patient Age47 YR
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