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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 Premature Activation (1484); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/08/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot# 73g1800873 investigation did not show issues related to the complaint.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that during laparoscopic cholecystectomy, a clip was not loaded into the jaws properly.At the second trial of loading, the clip got broken and fell in the patient's abdominal cavity.The fallen clip was retrieved and the user replaced the device with a new one to continue the surgery.
 
Manufacturer Narrative
(b)(4).Voided complaint: this report 3003898360-2019-00240 is being retracted, because it is a non-reportable event.Please make a note of it.
 
Event Description
It was reported that during laparoscopic cholecystectomy, a clip was not loaded into the jaws properly.At the second trial of loading, the clip got broken and fell in the patient's abdominal cavity.The fallen clip was retrieved and the user replaced the device with a new one to continue the surgery.
 
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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 Key8378132
MDR Text Key137414658
Report Number3003898360-2019-00240
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 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/29/2021
Device Catalogue NumberAE05ML
Device Lot Number73G1800873
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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