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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGAMAX ENDO CLIP APPLIER; CLIP, IMPLANTABLE

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ETHICON ENDO-SURGERY, LLC. LIGAMAX ENDO CLIP APPLIER; CLIP, IMPLANTABLE Back to Search Results
Catalog Number EL5ML
Device Problems Bent (1059); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/10/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(4).When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.The lot history records were reviewed and the manufacturing criteria were met prior to the release of the lot.(b)(4).
 
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Brand Name
LIGAMAX ENDO CLIP APPLIER
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
ETHICON ENDO-SURGERY, LLC.
475 calle c
guaynabo PR 00969
Manufacturer (Section G)
ETHICON ENDO-SURGERY, LLC
475 calle c
guaynabo PR 00969
Manufacturer Contact
milton garrett
4545 creek road ml 120a
cincinnati, OH 45242
5133378865
MDR Report Key5368260
MDR Text Key36353416
Report Number3005075853-2016-00315
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050344
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial
Report Date 01/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberEL5ML
Device Lot NumberM4HX06
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/07/2016
Initial Date FDA Received01/14/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Age64 YR
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