HOUSE EXCAVATOR N1705 55

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-05-20 for HOUSE EXCAVATOR N1705 55 manufactured by Storz Instrument Co..

Event Text Entries

[59070] While performing a stapedectomy procedure, a tiny tip of this instrument broke off. Another instrument was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1932180-1997-00051
MDR Report Key92652
Report Source06
Date Received1997-05-20
Date of Report1997-04-22
Date of Event1997-04-22
Date Facility Aware1997-04-22
Report Date1997-04-22
Date Reported to Mfgr1997-04-22
Date Mfgr Received1997-04-22
Date Added to Maude1997-05-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHOUSE EXCAVATOR
Generic NameEAR EXCAVATOR
Product CodeJYH
Date Received1997-05-20
Model NumberNA
Catalog NumberN1705 55
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age1 YR
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key91501
ManufacturerSTORZ INSTRUMENT CO.
Manufacturer Address499 SOVEREIGN CT. ST LOUIS MO 63011 US


Patients

Patient NumberTreatmentOutcomeDate
10 1997-05-20

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