KARL STORZ 27080C SAME

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-10-12 for KARL STORZ 27080C SAME manufactured by Karl Storz Gmbh & Co. Kg.

Event Text Entries

[712777] Dr was testing unit before procedure. A biotech was holding the probe and a container of water to fire probe in for testing purposes. Dr activated unit prematurely and biotech received a shock which left a red mark on her hand. She was sent to emergency, where she was given an ekg. There were no issues found, but she was sent home as a precaution. No medical treatment was necessary. When she returned to the hosp, she was checked again, and again medical treatment was unnecessary; she was released back to work.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number2020550-2007-00027
MDR Report Key933371
Date Received2007-10-12
Date of Report2007-10-04
Date of Event2007-08-06
Date Facility Aware2007-09-13
Report Date2007-10-12
Date Reported to FDA2007-10-12
Date Reported to Mfgr2007-10-12
Date Added to Maude2007-10-29
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameKARL STORZ
Generic NameCALCUTRIPT - LITHOTRIPTER
Product CodeLQS
Date Received2007-10-12
Model Number27080C
Catalog NumberSAME
Lot NumberNA
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age4 YR
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key905386
ManufacturerKARL STORZ GMBH & CO. KG
Manufacturer Address* TUTTLINGEN * GM

Patients

Patient NumberTreatmentOutcomeDate
101. Other 2007-10-12
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