* N1705-83J

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-17 for * N1705-83J manufactured by Storz.

Event Text Entries

[49684] Microrasp used during tympanomastoidectomy left ear canal. 1 mm piece not recovered. Pt d/c without ever locating piece.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 79033
• MDR Report Key: 79033
• Date Received: 1997-03-17
• Date of Report: 1997-03-11
• Date of Event: 1997-02-28
• Date Facility Aware: 1997-02-28
• Report Date: 1997-03-11
• Date Reported to FDA: 1997-03-11
• Date Reported to Mfgr: 1997-03-11
• Date Added to Maude: 1997-03-31
• 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: *
• Generic Name: *
• Product Code: JYY
• Date Received: 1997-03-17
• Model Number: N1705-83J
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 78640
• Manufacturer: STORZ
• Manufacturer Address: 499 SOVEREIGN CT MANCHESTER MO 63011 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-03-17