MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP* APPLIER W/MECH STOP; LIGACLIP APPLIER

Catalog Number LX107

Device Problem Failure to Form Staple (2579)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the device would not pinch the clips closed.There was no patient involvement.

Manufacturer Narrative

(b)(4).Date sent: 08/10/2018.The analysis results found that the lx107 device was received with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon functional testing of the device, the instrument loaded, retained and deployed 6 clips as intended.The instrument was fully functional and conforming to our manufacturing requirements.The event described could not be confirmed as the device performed without any difficulties noted.The batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.  the certificate records are accessible through external manufacturing. .

• Type of Device: LIGACLIP APPLIER
• 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: 7732032
• MDR Text Key: 115579786
• Report Number: 3005075853-2018-11683
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 20705036012853
• UDI-Public: 20705036012853
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/09/2018

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 Catalogue Number: LX107
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 07/25/2018
• Supplement Dates FDA Received: 08/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2000
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1