* 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 Number: 3400610000-2008-8030
• MDR Report Key: 1084717
• Date Received: 2008-07-07
• Date of Report: 2008-07-07
• Date of Event: 2008-05-15
• Report Date: 2008-07-07
• Date Reported to FDA: 2008-07-07
• Date Added to Maude: 2008-08-01
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Generic Name: CANNULA, HYSTEROSCOPY
• Product Code: NWW
• Date Received: 2008-07-07
• Model Number: *
• Catalog Number: 27040XA/XC
• Lot Number: GG
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: *
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 1049874
• Manufacturer: KARL STORZ ENDOSCOPY-AMERICA, INC.
• Manufacturer Address: 600 CORPORATE POINTE CULVER CITY CA 902307600 US

Device Sequence Number: 2

• Generic Name: CANNULA, HYSTEROSCOPY
• Product Code: NWW
• Date Received: 2008-07-07
• Model Number: *
• Catalog Number: 26040 XA
• Lot Number: AF
• ID Number: *
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: *
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 1049875
• Manufacturer: KARL STORZ ENDOSCOPY-AMERICA, INC.
• Manufacturer Address: 600 CORPORATE POINTE CULVER CITY CA 902307600 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-07-07