KARL STORZ 27040GPV NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2013-09-30 for KARL STORZ 27040GPV NA manufactured by Karl Storz Gmbh & Co..

Event Text Entries

[20855736] Allegedly, the doctor was performing a bipolar prostrate resection, procedure and when the electrode was activated, the patient experienced obturator nerve reaction and body jumped; this resulted in perforation of the bladder. Original procedure was completed and a catheter placed in patient to address perforation. Later, catheter was removed and patient condition is good at this time; perforation healed. There was no malfunction of karl storz instruments reported; it was determined that covidien force triad esu malfunctioned and produced too much energy which caused nerve stimulation. We filed 2 mdrs for 2 events. Reference mfr report number: 9610617-2013-00036.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3010202439-2013-00036
MDR Report Key3447165
Report Source99
Date Received2013-09-30
Date of Report2013-09-27
Date of Event2013-08-23
Date Facility Aware2013-08-29
Report Date2013-09-27
Date Reported to FDA2013-09-27
Date Reported to Mfgr2013-09-27
Date Added to Maude2013-11-05
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
Manufacturer Street2151 E. GRAND AVENUE
Manufacturer CityEL SEGUNDO CA 902450000
Manufacturer CountryUS
Manufacturer Postal902450000
Manufacturer G1KARL STORZ ENDOSCOPYAMERICA INC.
Manufacturer Street2151 E. GRAND AVENUE
Manufacturer CityEL SEGUNDO CA 90245000
Manufacturer CountryUS
Manufacturer Postal Code90245 0000
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameKARL STORZ
Generic NameBIPOLAR ELECTRODE
Product CodeHIN
Date Received2013-09-30
Model Number27040GPV
Catalog NumberNA
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Sequence No1
Device Event Key0
ManufacturerKARL STORZ GMBH & CO.
Manufacturer AddressTUTTLINGEN GM


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-09-30

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