AUTO ENDO5 ML AE05ML

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 2020-03-24 for AUTO ENDO5 ML AE05ML manufactured by Teleflex Medical.

Event Text Entries

[184805667] (b)(4). The device history review for the product auto endo5 ml lot #73g1900662 investigation did not show issues related to the complaint. The device investigation is pending. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10


[184805668] The report states: we had an incident on 2/28 with a couple of endo clip appliers item number ae05ml they were both different lot numbers. Per the nurse when they deployed it, there was a delay and so they took it out of the patient's body and the metal tip/clip broke and stayed in the patient's body. We have both of these in a red bag i don't know if we can ship them off to be reviewed. The doctor also has pictures of what exactly happened if you would like those. The lot numbers are: 73g1900661 and 73g1900662.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3003898360-2020-00292
MDR Report Key9873144
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-24
Date of Report2020-03-06
Date of Event2020-02-28
Date Mfgr Received2020-03-06
Device Manufacturer Date2019-07-23
Date Added to Maude2020-03-24
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 ContactEFFIE JEFFERSON
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194332672
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetRANCHO EL DESCANSO
Manufacturer CityTECATE 21478
Manufacturer CountryMX
Manufacturer Postal Code21478
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAUTO ENDO5 ML
Generic NameCLIP, IMPLANTABLE
Product CodeFZP
Date Received2020-03-24
Returned To Mfg2020-03-13
Catalog NumberAE05ML
Lot Number73G1900662
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressMORRISVILLE NC


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

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