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

Catalog Number ER320

Device Problems Bent (1059); Failure to Form Staple (2579); Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/30/2015

Event Type  malfunction  

Event Description

It was reported that during a lap nephroureterectomy procedure the device clips were pre-bent and not sitting in the jaws, the clips would not apply to the tissue.A second device was pulled to complete the procedure with no patient consequence.There is no further information about the event.

Manufacturer Narrative

(b)(4).Should the information be provided later, a supplemental medwatch will be sent.The er320 device was returned for analysis and upon inspection the jaws were found to be in a yielded condition.In an attempt to replicate the reported incident the device was functionally evaluated.Upon firing of the device, the remaining clips were ejected due to the condition of the jaws; finally the instrument locked out as intended.Possible causes for the found condition of the yielded jaws may be if the device is closed over an existing hard object or clip placing stress on the jaws causing them to distort or yield and not return to their original dimensions/position or excessive application of torque to the jaws when positioning the device on a vessel.

• Brand Name: LIGACLIP 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: 4756933
• MDR Text Key: 5790137
• Report Number: 3005075853-2015-02888
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K864102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2015

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: 11/08/2019
• Device Catalogue Number: ER320
• Device Lot Number: L4FH0U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2015
• Initial Date FDA Received: 05/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2014
• 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