KARL STORZ 26002M *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-06 for KARL STORZ 26002M * manufactured by Karl Storz Endoscopy-america, Inc..

Event Text Entries

[71366] During a pelviscopy procedure, the high frequency cord used with the monopolar endoscopic instrument caught on fire at the joint between the connector to the esu and the cord, severing the cord into two pieces. The fire extinguished itself when the cord was burnt in two. This was the second occurrence of the same event with a different cord.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1012235
MDR Report Key124662
Date Received1997-10-06
Date of Report1997-10-03
Date of Event1997-09-29
Date Added to Maude1997-10-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameKARL STORZ
Generic NameHIGH FREQUENCY CORD
Product CodeFFZ
Date Received1997-10-06
Model Number26002M
Catalog Number*
Lot NumberAP03
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key122044
ManufacturerKARL STORZ ENDOSCOPY-AMERICA, INC.
Manufacturer Address600 CORPORATE POINTE CULVER CITY CA 902307600 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-10-06

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