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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 AE05ML
Device Problems Break (1069); Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot #73b1900055 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that while using the applier, the user faced an issue with it.The clips were stuck in the applier; difficult to get out of the applier and one clip came out broken from the applier.So, we could not use this applier.Another device was used.
 
Manufacturer Narrative
(b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint (b)(4) is being reported as a malfunction.There was no serious injury.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8956389
MDR Text Key156308869
Report Number3003898360-2019-01062
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
PMA/PMN Number
K152081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 08/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/03/2022
Device Catalogue NumberAE05ML
Device Lot Number73B1900055
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/05/2019
Date Manufacturer Received09/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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