MULTI CLIP APPLIER LIGACLIP SMALL CLIPS ETHMCS20

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-12 for MULTI CLIP APPLIER LIGACLIP SMALL CLIPS ETHMCS20 manufactured by Sterilmed, Inc..

Event Text Entries

[142755045] The device is available for return, however has not yet been returned. We are working on obtaining manufacturing record evaluation, once we get more information it will be submitted in the supplemental. The following report numbers are related to the same event: 2134070-2019-00124, 2134070-2019-00125, 2134070-2019-00126. Manufacturer's ref. No: (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[142755046] It was reported that a patient underwent a procedure with two multi clip applier ligaclip small clips and one multiple clip applier ligaclip mca and all of the devices has scissoring clips. The devices were exchanged to complete the procedure. The intent of the procedure was not altered as a result of this event. There was no patient injury or consequence. No further information has been made available. This report is for the second of the two multi clip applier ligaclip small clips.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2134070-2019-00125
MDR Report Key8510431
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-04-12
Date of Report2019-03-20
Date Mfgr Received2019-05-13
Device Manufacturer Date2018-09-12
Date Added to Maude2019-04-12
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 ContactMR. GABRIEL ALFAGEME
Manufacturer Street31 TECHNOLOGY DR
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal92618
Manufacturer Phone9497898687
Manufacturer G1STERILMED, INC.
Manufacturer Street5010 CHESHIRE PARKWAY STE 2
Manufacturer CityPLYMOUTH MN 55446
Manufacturer CountryUS
Manufacturer Postal Code55446
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMULTI CLIP APPLIER LIGACLIP SMALL CLIPS
Generic NameCLIP, IMPLANTABLE, REPROCESSED
Product CodeNMJ
Date Received2019-04-12
Returned To Mfg2019-05-13
Catalog NumberETHMCS20
Lot Number2071732
Device Expiration Date2019-09-12
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTERILMED, INC.
Manufacturer Address5010 CHESHIRE PARKWAY STE 2 PLYMOUTH MN 55446 US 55446


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-12

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