MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP

Catalog Number EL214

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device analysis: the el214 device was returned for analysis and upon inspection the jaws were found to be in a yielded condition.Upon testing, the device loaded and retained the clips as intended; however, the clips were not properly formed due to the condition of the jaws.Possible causes for the condition found 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.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The batch history records were reviewed and certed by external manufacturing that themanufacturing criteria was met prior to the release of the equipment.Additional information was requested and the following was obtained: how did the device malfunction? the device would not hold clips when being loaded on the back table.Were the jaws misaligned? they said jaws were perpendicular to cartridge when loading.Did the device not hold a clip in the jaws? yes.Clip would not stay in jaws.Did the device jaws not close? jaws did not close when clip was attempting to be loaded.With no clip, jaws close.Did the device not close the clip (firing issue)? the clip could not be loaded to get to this step.Did the device deploy a malformed clip (unformed, malformed, scissored, etc.)? unformed.

Event Description

It was reported that during an unknown procedure, the clip applier open and malfunctioned.Another like device was used to complete the procedure.There were no adverse consequences for the patient.

• Brand Name: LIGACLIP
• Type of Device: LIGACLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 6893902
• MDR Text Key: 89411560
• Report Number: 3005075853-2017-04851
• Device Sequence Number: 1
• Product Code: HBT
• Combination Product (y/n): N
• PMA/PMN Number: K830503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EL214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Date Manufacturer Received: 09/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1