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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP* APPLIER W/MECH STOP; LIGACLIP APPLIER
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ETHICON ENDO-SURGERY, LLC. LIGACLIP* APPLIER W/MECH STOP; LIGACLIP APPLIER Back to Search Results
Catalog Number LX107
Device Problems Bent (1059); Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Date sent: 3/12/2018.Only event year known: 2018.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
It was reported that the tip of the clip applier is bent and won't apply the clips properly.No patient involvement was reported.
 
Manufacturer Narrative
(b)(4).Device analysis: the analysis results found that the lx107 device was received with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon functional testing of the device, the instrument loaded, retained and deployed 6 clips as intended.The instrument was fully functional and conforming to our manufacturing requirements.No conclusion could be reached as to what may have caused the reported incident.The batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment. .
 
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Type of Device
LIGACLIP APPLIER
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo 00969
MDR Report Key7332066
MDR Text Key102209025
Report Number3005075853-2018-08495
Device Sequence Number1
Product Code GDO
UDI-Device Identifier20705036012853
UDI-Public20705036012853
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberLX107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2018
Date Manufacturer Received03/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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