MIC1332

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-08-29 for MIC1332 manufactured by Sterilmed, Inc..

Event Text Entries

[53444547] The device has not yet been returned to the manufacturer at the time of this report. A supplemental form will be sent once the evaluation is completed if the device is returned. The device history report was reviewed and no discrepancies were found.
Patient Sequence No: 1, Text Type: N, H10


[53444548] It was reported that the device was tested by opening and closing prior to placing it in the scope. Upon opening while in the patient to retrieve a biopsy, the forceps broke. Fragments or pieces were not left in the patient. No harm was detected to patient. Additional information was requested, but additional information is not available.
Patient Sequence No: 1, Text Type: D, B5


[55737143] The device was returned to the manufacturer with clearly damaged jaws including a compromised mechanism for opening and closing the jaws. While the jaws of the device were able to open and close, the alignment was off as well as clear and present damage. Due to the presence of contaminants as well as the statement of use following function testing in the field, the root cause was likely misuse or mishandling in the field.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2134070-2016-00063
MDR Report Key5912464
Report SourceHEALTH PROFESSIONAL
Date Received2016-08-29
Date of Report2016-09-27
Date Mfgr Received2016-09-26
Device Manufacturer Date2016-04-25
Date Added to Maude2016-08-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJASON ANDERSON
Manufacturer Street5010 CHESHIRE PARKWAY SUITE 2
Manufacturer CityPLYMOUTH MN 55426
Manufacturer CountryUS
Manufacturer Postal55426
Manufacturer Phone7634888348
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameFORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED
Product CodeNON
Date Received2016-08-29
Returned To Mfg2016-09-26
Model NumberMIC1332
Catalog NumberMIC1332
Lot Number1942760
Device Expiration Date2017-04-25
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTERILMED, INC.
Manufacturer Address11400 73RD AVE N MAPLE GROVE MN US


Patients

Patient NumberTreatmentOutcomeDate
10 2016-08-29

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