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

Catalog Number EL5ML

Device Problems Bent (1059); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2015

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic sleeve gastrectomy procedure, as per hospital documentation submitted with this document - "hand piece not working/release clips and seems like a bend above the handle." further information to be provided by sales representative when available.It is unknown what was used to complete the procedure.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Should the information be provided later, a supplemental medwatch will be sent.Additional information was requested and the following was obtained: how did device not work, did clips not deploy or release? dr.Was applying clip on anastomosis site (edge) he started complaining when the instrument (he thought) went 'wobbly' or bending.Where was the bend on the device (was shaft bent)? he could not release clips when he noticed the issue.How was case completed? we had to open another one (ligamax) to proceed with the operation to achieve hemostasis.The analysis results for the el5ml device found that it was returned with the shaft slightly bent.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 five conforming clips.In addition the device locked out as intended.Possible causes for the damage found may be inadvertent pressure placed on the device shaft through bending, pressing against the trocar, other devices on the back table, using the device as a retractor or moving heavy tissue with the device shaft.

• Brand Name: LIGAMAX CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• 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: 4685201
• MDR Text Key: 5635397
• Report Number: 3005075853-2015-02293
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2015

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: 10/22/2019
• Device Catalogue Number: EL5ML
• Device Lot Number: L4FE85
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2015
• Initial Date FDA Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2014
• 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