ETHER420 ER420

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 2014-10-27 for ETHER420 ER420 manufactured by Sterilmed, Inc..

Event Text Entries

[5001661] It was reported that upon the first firing and for all subsequent firings of the device the clip tips did not meet but crossed deploying an incorrect tip alignment. A second device also had the same issue. There was no pt injury. It was later reported that the devices had been fired on a small vessel. Small vessel bleeding was reported. A third device from another mfr was used to complete the case. No cholangiogram was performed on the procedure. There was no torquing or twisting of the device present at the time of firing. The clips was fully advanced into the jaws prior to firing, and a clip could be visualized in the jaws prior to firing. There were no feeding issues experienced. The clips were not fired over another clip or hard structure. This report is being filed for the second device. See related mfr report #: 2134070-2014-00183.
Patient Sequence No: 1, Text Type: D, B5


[12602101] Final device eval found that the device was returned in good visual condition. Upon evaluation, the handle and shaft were visually acceptable. The jaw appeared to be in alignment and the clip retainer, push fork and jaw clearance were acceptable. The device was then cycled, fed and produced the eight remaining clips with proper pinch and alignment. After the last clip was fired, the locking mechanism engaged as intended. The device history record was reviewed, and no discrepancies were noted. As the device operated as intended during eval, no conclusion could be made as to what may have caused the reported event.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2134070-2014-00182
MDR Report Key4224526
Report Source05,07
Date Received2014-10-27
Date of Report2014-10-01
Date of Event2014-10-01
Date Mfgr Received2014-10-01
Device Manufacturer Date2014-07-01
Date Added to Maude2014-11-18
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 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 NameCLIP, IMPLANTABLE, REPROCESSED
Product CodeNMJ
Date Received2014-10-27
Returned To Mfg2014-10-13
Model NumberETHER420
Catalog NumberER420
Lot Number1781847
Device Expiration Date2015-07-31
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 2014-10-27

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