* 27040XA/XC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-07 for * 27040XA/XC manufactured by Karl Storz Endoscopy-america, Inc..

Event Text Entries

[914574] The hysteroscopy stortz cannula has a ceramic tip approximately 5cm long. The obturator that fits inside the cannula is metal and it can articulate up and down. It appears that the metal tip on the obturator may have caused the ceramic tip to break off in 2 pieces. A second set was opened and the exact same break occurred. The surgeon was very experienced; therefore the break was not due to inexperience. All pieces of the instrument were believed to be recovered (an x ray was not taken because the pieces appear to fit together).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3400610000-2008-8030
MDR Report Key1084717
Date Received2008-07-07
Date of Report2008-07-07
Date of Event2008-05-15
Report Date2008-07-07
Date Reported to FDA2008-07-07
Date Added to Maude2008-08-01
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 Sequence Number: 1

Generic NameCANNULA, HYSTEROSCOPY
Product CodeNWW
Date Received2008-07-07
Model Number*
Catalog Number27040XA/XC
Lot NumberGG
ID Number*
OperatorPHYSICIAN
Device AvailabilityY
Device Age2 YR
Implant Flag*
Date Removed*
Device Sequence No1
Device Event Key1049874
ManufacturerKARL STORZ ENDOSCOPY-AMERICA, INC.
Manufacturer Address600 CORPORATE POINTE CULVER CITY CA 902307600 US

Device Sequence Number: 2

Generic NameCANNULA, HYSTEROSCOPY
Product CodeNWW
Date Received2008-07-07
Model Number*
Catalog Number26040 XA
Lot NumberAF
ID Number*
Device AvailabilityY
Device Age2 YR
Implant Flag*
Date Removed*
Device Sequence No2
Device Event Key1049875
ManufacturerKARL STORZ ENDOSCOPY-AMERICA, INC.
Manufacturer Address600 CORPORATE POINTE CULVER CITY CA 902307600 US


Patients

Patient NumberTreatmentOutcomeDate
10 2008-07-07

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