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 2016-06-09 for MIC1332 manufactured by Sterilmed, Inc..

Event Text Entries

[46919718] 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


[46919719] It was reported that following a procedure, during cleaning with tap water and a gauze, black residue was noticed on the device. There has been no patient harm or consequence reported. Follow up has been requested should any further patient information come available.
Patient Sequence No: 1, Text Type: D, B5


[49639760] The device was returned in good visual condition. During evaluation, the entire length of the device shaft was wiped down with tap water and produced light black residue marks on the cloth as reported by the user facility. A second wipe down with 70% isopropyl alcohol was then performed. It was discovered that while performing the second wipe down over the black lines on the shaft, the transfer of black residue on the cloth was heavier. There was no transfer of black residue observed on the cloth when wiping down the orange section of the shaft. In order to determine root cause, fifteen unused, reprocessed devices of the same model were then evaluated. Findings from this evaluation showed the same black residue coming off the black lines and transferring onto the cloth. The devices are manufactured with a black ink on the sheath. The black residue was identified as a transfer of black ink that is used in original device production by the original equipment manufacturer (oem). An evaluation was also performed on a new non-reprocessed oem device and the same findings were observed indicating that the cause of the issue is not associated with reprocessing. There have been no other reported complaints for this issue from other facilities. The device history record was reviewed and no discrepancies were noted.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2134070-2016-00039
MDR Report Key5709554
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2016-06-09
Date of Report2016-05-17
Date of Event2016-05-13
Date Mfgr Received2016-07-15
Device Manufacturer Date2016-03-03
Date Added to Maude2016-06-09
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 PARWAY 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 Received2016-06-09
Returned To Mfg2016-06-07
Model NumberMIC1332
Catalog NumberMIC1332
Lot Number1932392
Device Expiration Date2017-03-03
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 2016-06-09

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