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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGAMAX 5MM; CLIP, IMPLANTABLE

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ETHICON ENDO-SURGERY, LLC. LIGAMAX 5MM; 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 03/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Information was not provided by the contact.Information anticipated, but unavailable at this time.
 
Event Description
It was reported that during a laparoscopic cholecystectomy procedure, the device was used to clip a vessel.Clips did not close correctly, the legs were bent.At least six clips were not formed properly.It is unknown what was used to complete the procedure.There were no adverse consequences for the patient reported.
 
Manufacturer Narrative
(b)(4).Batch # = n9019x.The analysis results found that the el5ml device was returned in good visual condition.In addition, 2 malformed clips were received in a plastic bag.In an attempt to replicate the reported incident, the instrument was tested for functionality.During the analysis, the device was cycled and it fed and formed 10 clips as intended.In addition, the device locked out as intended.During functional testing no malformed clips were noted.No conclusion could be reached as to what may have caused the reported incident.A batch record review was performed and no anomalies were found during the manufacturing process.
 
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Brand Name
LIGAMAX 5MM
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 Key5581034
MDR Text Key43444605
Report Number3005075853-2016-02054
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K050344
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/23/2016
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 Expiration Date12/12/2020
Device Catalogue NumberEL5ML
Device Lot NumberM4HE6G
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/22/2016
Initial Date FDA Received04/15/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/29/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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