STRAIGHT COLD KNIFE * 27069K

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-29 for STRAIGHT COLD KNIFE * 27069K manufactured by Karl Storz Endoscopy America, Inc.

Event Text Entries

[21658487] Patient underwent a cystoscopic transurethral incision of the bladder neck. At the close of the case it was noted that the end of the cold knife was missing. The surgeon performed another cystoscopy to locate the tip. The patient had to be placed under general anesthesia. The blade tip was eventually able to be retrieved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2839332
MDR Report Key2839332
Date Received2012-10-29
Date of Report2012-10-29
Date of Event2010-08-23
Report Date2012-10-29
Date Reported to FDA2012-10-29
Date Added to Maude2012-11-20
Event Key0
Report Source CodeUser Facility 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 FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSTRAIGHT COLD KNIFE
Generic NameURETHROTOME, COLD KNIFE
Product CodeEZO
Date Received2012-10-29
Model Number*
Catalog Number27069K
Lot Number38904
ID Number*
Device AvailabilityY
Device Age1 DY
Device Sequence No1
Device Event Key0
ManufacturerKARL STORZ ENDOSCOPY AMERICA, INC
Manufacturer Address2151 E. GRAND AVE EL SEGUNDO CA 90245 US 90245


Patients

Patient NumberTreatmentOutcomeDate
10 2012-10-29

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