LITHOTRITE * 27076 A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-16 for LITHOTRITE * 27076 A manufactured by Karl Storz Endoscopy-america Inc.

Event Text Entries

[74699] Lithotrite caught in the cystoscope- m. D. Unable to remove lithotrite from cystoscope sheath. It appeared lithotrite malfunctioned causing the jaws not to open and getting stuck in cystoscope sheath.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1012346
MDR Report Key127954
Date Received1997-10-16
Date of Event1997-10-09
Date Added to Maude1997-10-27
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameLITHOTRITE
Generic NameMECHANICAL LITHOTRITE
Product CodeFGK
Date Received1997-10-16
Model Number*
Catalog Number27076 A
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key125202
ManufacturerKARL STORZ ENDOSCOPY-AMERICA INC
Manufacturer Address91 CARPENTER HILL RD CHARLTON MA 015073578 US


Patients

Patient NumberTreatmentOutcomeDate
10 1997-10-16

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