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

Catalog Number EL5ML

Device Problems Fitting Problem (2183); Failure to Align (2522); Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: the analysis results found that the el5ml device was received with one jaw disengaged from the cam; this condition would not allow the jaws to collapse in order to form the clips.In an attempt to replicate the reported incident, the device was tested for functionality.Upon firing of the device, one clip was ejected due to the jaw condition.In order to evaluate the performance of the device, the jaw was readjusted and in the next actuations, six conforming clips were fed and formed; finally the device locked out as intended.Possible causes for the condition of the jaw disengaged from the cam may be inadvertent force, twisting or pressure being placed on the device jaws, using the jaws of the device as a dissector/retractor or damage to the jaws while entering the trocar.It is known from the history of the device that the disengagement of the jaws may have cause difficulties to insert and/or remove the instrument through the trocar.The batch record was reviewed and no anomalies were noted during the manufacturing process.

Event Description

It was reported that during an unknown procedure, there was an issue with the device out of a laparoscopic cholecystectomy tray.It would not fit into the port, the user kept squeezing it but the jaw was out of alignment so it would not fit in the port and it would not close properly to shut the clip so we had to open a separate device.There was no patient consequence.

Manufacturer Narrative

(b)(4).

• Brand Name: LIGAMAX 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 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4200968
• MDR Text Key: 12470850
• Report Number: 3005075853-2014-07356
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2019
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2014
• 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
• Treatment: KIT - LCB54S LOT# L91W8X