MIC1333

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-05-24 for MIC1333 manufactured by Sterilmed, Inc..

Event Text Entries

[2661665] It was reported that during a procedure, the jaws of a biopsy forceps were stuck in a closed position.
Patient Sequence No: 1, Text Type: D, B5


[9872785] Final investigation showed that the jaws were able to open and close, and that the device operated as designed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2134070-2012-00088
MDR Report Key2591233
Report Source05,07
Date Received2012-05-24
Date of Report2011-10-05
Date Mfgr Received2011-10-05
Device Manufacturer Date2011-07-01
Date Added to Maude2012-06-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactTRICIA SCHRATER
Manufacturer Street11400 73RD AVE. NORTH
Manufacturer CityMAPLE GROVE MN 55369
Manufacturer CountryUS
Manufacturer Postal55369
Manufacturer Phone7634883211
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNA
Generic NameCOLD BIOPSY FORCEPS (NON)
Product CodeNON
Date Received2012-05-24
Returned To Mfg2011-10-11
Model NumberMIC1333
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTERILMED, INC.
Manufacturer AddressMAPLE GROVE MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2012-05-24

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