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

Catalog Number LX107

Device Problems Peeled/Delaminated (1454); Failure to Form Staple (2579); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: only event year known: 2019.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 manufacturing record evaluation was performed and identified a issue related to the reported incident.The necessary actions to ensure the final product quality have been taken and documented in the appropriate quality system.The final quality release criteria were met before this batch was released for distribution.The certificate records are accessible through external manufacturing.

Event Description

It was reported that devices have plastic coating chipping off, some have the tips bent and some do not hold clips.There is no additional information.No patient consequences were reported.

• Type of Device: APPLIER, SURGICAL, CLIP
• 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: 8568983
• MDR Text Key: 143884314
• Report Number: 3005075853-2019-18639
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036012856
• UDI-Public: 10705036012856
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• 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: 04/03/2019
• Date Manufacturer Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1