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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); Ejection Problem (4009)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/17/2018
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).The device has not bee returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that during a laparoscopic low anterior resection, the second clip was slanted when loaded into the jaws, a clip fell, the jaws would not fully open, and a clip broke.
 
Manufacturer Narrative
Qn#(b)(4).Voided complaint: it was reported multiple clips having issues from one device, however; there is only one device involved.This is a duplicate complaint of mdr file#3003898360-2019-00040.Please make a note of this voided complaint for your records.
 
Event Description
It was reported that during a laparoscopic low anterior resection, the second clip was slanted when loaded into the jaws, a clip fell, the jaws would not fully open, and a clip broke.
 
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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 Key8227645
MDR Text Key132414758
Report Number3003898360-2019-00041
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 company representative,foreig
Type of Report Initial,Followup
Report Date 12/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/10/2021
Device Catalogue NumberAE05ML
Device Lot Number73G1800294
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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