KARL STORZ COLD KNIFE 27068K

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-03-03 for KARL STORZ COLD KNIFE 27068K manufactured by Karl Storz Gmbh & Co. Kg.

Event Text Entries

[20929028] During a urethrectomy, the blade of the cold knife allegedly broke off and fell into pt. Length of procedure was extended in order to retrieve piece. Pt was required to be hospitalized rather than released as outpatient procedure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2020550-2003-00003
• MDR Report Key: 446669
• Date Received: 2003-03-03
• Date of Report: 2003-02-28
• Date of Event: 2003-01-28
• Date Facility Aware: 2003-02-04
• Report Date: 2003-02-28
• Date Reported to FDA: 2003-03-03
• Date Reported to Mfgr: 2003-03-03
• Date Added to Maude: 2003-03-11
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• 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 Details

• Brand Name: KARL STORZ COLD KNIFE
• Generic Name: COLD KNIFE
• Product Code: EZO
• Date Received: 2003-03-03
• Model Number: 27068K
• Catalog Number: 27068K
• Lot Number: 8589
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 8 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 435635
• Manufacturer: KARL STORZ GMBH & CO. KG
• Manufacturer Address: MITTELSTRASSE 8 POSTFACH 230 TUTTLINGEN GM 78503
• Baseline Brand Name: KARL STORZ
• Baseline Generic Name: URETHROTOME KNIFE
• Baseline Model No: 27068K
• Baseline Catalog No: 27068K
• Baseline ID: NA
• Baseline Device Family: KNIFE
• Baseline Shelf Life Contained: N
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K934730
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2003-03-03