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

Catalog Number	EL414
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device analysis: the analysis results confirmed that the el414 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 if the device is closed over an existing hard object or clip placing stress on the jaws 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.  the certificate records are accessible through external manufacturing. .
Event or Problem Description
It was reported that during a tlh procedure, product was not working.Not able to hold clip in jaws.

• Common Device Name: APPLIER, HEMOSTATIC CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8600239
• Report Number: 3005075853-2019-18978
• Device Sequence Number: 2935138
• Product Code: HBT
• UDI-Device Identifier: 10705036003861
• UDI-Public: 10705036003861
• Combination Product (Y/N): N
• PMA/510(K) Number: K830503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2019

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: EL414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/10/2019
• Patient Sequence Number: 1