MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*SINGLE CLIP APPLIER; APPLIER, SURGICAL, CLIP

Catalog Number LC320

Device Problem Defective Device (2588)

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 lc320 device was returned nonfunctional as the jaws were misaligned.Functional test was performed on one clip, it was loaded and retained as intended, but due to the damaged jaws, the clip formation was not proper.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 certified 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 there was an unknown issue with the device.

Manufacturer Narrative

(b)(4).

• Type of Device: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8491080
• MDR Text Key: 141456744
• Report Number: 3005075853-2019-17861
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036012672
• UDI-Public: 10705036012672
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LC320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Date Manufacturer Received: 04/04/2019
• Patient Sequence Number: 1