STORZ REF# E4220 00 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-02-10 for STORZ REF# E4220 00 * manufactured by Storz Instrument Co.

Event Text Entries

[173296] A brand new quickest probe was bent at the end by the physician to facilitate passing it through the right nares. When he pulled it out a 6mm piece was broken off and unable to be found. X-ray of the head revealed it was lodged somewhere in the right nares; possibly the turbinates. Nasal endoscopy did not reveal the piece.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 213276
• MDR Report Key: 213276
• Date Received: 1999-02-10
• Date of Report: 1999-02-10
• Date of Event: 1999-01-22
• Date Facility Aware: 1999-01-22
• Report Date: 1999-02-10
• Date Reported to FDA: 1999-02-10
• Date Added to Maude: 1999-03-11
• 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
• 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: STORZ
• Generic Name: PROBE, LACRIMAL QUICKEST
• Product Code: KAK
• Date Received: 1999-02-10
• Model Number: REF# E4220 00
• Catalog Number: *
• Lot Number: UNK
• ID Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 1 DAY
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 206931
• Manufacturer: STORZ INSTRUMENT CO
• Manufacturer Address: 3365 TREE CT INDUSTRIAL BLVD ST. LOUIS MO 63122 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-02-10