OTIS URETHROTOME UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-26 for OTIS URETHROTOME UNKNOWN manufactured by Karl Storz Gmbh & Co..

Event Text Entries

[18476270] See attached user report
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2020550-1994-00015
• MDR Report Key: 13687
• Date Received: 1994-04-26
• Date of Report: 1994-04-11
• Date of Event: 1993-12-06
• Date Facility Aware: 1994-04-04
• Report Date: 1994-04-11
• Date Reported to FDA: 1994-04-11
• Date Reported to Mfgr: 1994-04-11
• Date Added to Maude: 1994-06-02
• 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: OTIS URETHROTOME
• Generic Name: URETHROTOME
• Product Code: EZO
• Date Received: 1994-04-26
• Model Number: UNKNOWN
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: B
• Device Sequence No: 1
• Device Event Key: 13685
• Manufacturer: KARL STORZ GMBH & CO.
• Manufacturer Address: MITTELSTRASSE 8 78532 TUTTLINGGEN GM

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-04-26