MIC1332

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-10-24 for MIC1332 manufactured by Sterilmed, Inc..

Event Text Entries

[58250495] 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


[58250496] 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 device broke. It was noted that no fragments or pieces were left in the patient. It was reported that there was no harm detected to the patient.
Patient Sequence No: 1, Text Type: D, B5


[60884226] The biopsy forceps were returned with a clearly damaged jaw, and a portion of the mechanism that opens and closes the jaw was out of position. The device was examined and contaminants consistent with exposure, if not use, were found to be present. The device was able to open and close without issue. The root cause for the damage was undetermined, however, as the device was used in the field, the device may have been mishandled or damaged during its use.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2134070-2016-00075
MDR Report Key6052173
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2016-10-24
Date of Report2016-09-26
Date Mfgr Received2016-11-18
Device Manufacturer Date2016-04-19
Date Added to Maude2016-10-24
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 55446
Manufacturer CountryUS
Manufacturer Postal55446
Manufacturer Phone7634888348
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameFORCEPS, BIOPSY, NON-ELECTRIC, REPROCESSED
Product CodeNON
Date Received2016-10-24
Returned To Mfg2016-11-18
Model NumberMIC1332
Catalog NumberMIC1332
Lot Number1941416
Device Expiration Date2017-04-19
OperatorHEALTH PROFESSIONAL
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 2016-10-24

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