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

Catalog Number	LC320
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that there was an unknown issue with the device.
Additional Manufacturer Narrative
(b)(4).

• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8491080
• Report Number: 3005075853-2019-17861
• Device Sequence Number: 11233978
• Product Code: GDO
• UDI-Device Identifier: 10705036012672
• UDI-Public: 10705036012672
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: LC320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 04/04/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 04/08/2019
• Patient Sequence Number: 1