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

Catalog Number LX107

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event is 2020.Event day and event month were not reported.Investigation summary: the analysis results confirmed that the lx107 device was returned nonfunctional as jaws were found to be in a yielded condition therefore, the clips could not be loaded into the jaws.Possible causes for this condition may be due to the device being closed over an existing hard object or clip, thus placing stress on the jaws and 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.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. .

Event Description

It was reported that the clip applier was not holding clips.No patient involvement was reported (there was no patient consequence).

• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10005432
• MDR Text Key: 199047158
• Report Number: 3005075853-2020-02374
• 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
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2020

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: 04/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/02/2020
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2012
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1