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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO MED/LG APPLIER
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ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO MED/LG APPLIER Back to Search Results
Catalog Number EL314
Device Problems Failure to Form Staple (2579); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/19/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
During the surgical procedure, the applied clips were being used and the doctor says, "it does not work properly, it does not turn, it does not tighten, it releases the staples".There were no consequences, since the doctor, seeing that the staples were loose, stopped using them and kept stapling with other material.Procedure completed with a disposable clip applier.Procedure: laparoscopic cholecystectomy.
 
Manufacturer Narrative
(b)(4).Date sent: 03/23/2018.Additional information received: the product was discarded.
 
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Type of Device
LIGACLIP
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key7179543
MDR Text Key96952610
Report Number3005075853-2018-07204
Device Sequence Number1
Product Code HBT
UDI-Device Identifier20705036003851
UDI-Public20705036003851
Combination Product (y/n)N
PMA/PMN Number
K830503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEL314
Was Device Available for Evaluation? No
Date Manufacturer Received03/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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