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

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.

• 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 Key: 5581034
• MDR Text Key: 43444605
• Report Number: 3005075853-2016-02054
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• 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 Date: 12/12/2020
• Device Catalogue Number: EL5ML
• Device Lot Number: M4HE6G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2016
• Initial Date FDA Received: 04/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1