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

Catalog Number ER320

Device Problems Bent (1059); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information : the analysis results of the er320 device found that it was received with a clip in the jaws; the clip was removed in order to inspect the jaws and they were found to be misaligned and yielded.In addition, a bag with a scissored clip was returned along with the instrument.In an attempt to replicate the reported incident, the device was tested for functionality; during the analysis, the instrument was cycled and it fed and formed nine scissored clips due to the misaligned condition of the jaws.Possible causes for the condition of the 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.

Event Description

It was reported that during an unknown procedure there were bent and crooked staples.It was not known how the case was completed.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).No device received for analysis at time of submission of 3500a.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.

• 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: 4726474
• MDR Text Key: 13363342
• Report Number: 3005075853-2015-02596
• 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,Followup
• Report Date: 04/16/2015

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: 09/09/2019
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 04/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1