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

Catalog Number LX107

Device Problem Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2018.Device analysis: the analysis results confirmed that the lx107 device was returned nonfunctional as the jaws were misaligned; therefore, the clips could not be loaded into the jaws.It is possible that the damaged was due to an improper handling of the device.Please note that as stated in the ifu: "all surgical instruments are subject to a degree of wear and tear because of normal use.A regular and precise visual check of the instrument should be made before each use.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. .

Event Description

It was reported that the jaws are mis-aligned.This was found while cleaning the device.No patient involvement.

• 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: 7928113
• MDR Text Key: 122481005
• Report Number: 3005075853-2018-13148
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 20705036012853
• UDI-Public: 20705036012853
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2018
• Initial Date Manufacturer Received: 09/07/2018
• Initial Date FDA Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2017
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1