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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE
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TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE Back to Search Results
Catalog Number 543965
Device Problems Premature Activation (1484); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/11/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review could not be conducted since the lot number was not provided.The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that first some clips fell from the applier into the patient body because they were unable to be loaded into the jaws properly.As a result of this, a new one was used instead.All clips in the patient were removed without problem and no health injury was reported.
 
Manufacturer Narrative
(b)(4).Dhr review could not be conducted since the lot number was not provided.Revision of pfmea-08-029 rev 04 was performed and the failure mode is already including it, no update is required.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.At this time due the sample is not available is not possible to determine the source of the defect reported.Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
 
Event Description
It was reported that first some clips fell from the applier into the patient body because they were unable to be loaded into the jaws properly.As a result of this, a new one was used instead.All clips in the patient were removed without problem and no health injury was reported.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate 21478
MX   21478
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key7245204
MDR Text Key99224675
Report Number3003898360-2018-00042
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K021808
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number543965
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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