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

Catalog Number	EL314
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: the product was returned for evaluation.Visual inspection and functional testing were conducted on the returned device.Upon visual analysis of the returned sample, it was determined that the el314 device was returned nonfunctional as the jaws were yielded, therefore, the clips could not be loaded into the jaws.Please note that as stated in the instructions for use: "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." as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the device.The certificate records are accessible through external manufacturing.¿.
Event or Problem Description
It was reported that during a cholecystectomy procedure, the lap clip applier jaw was opened and was not working.It is unknown how the procedure was completed.There was no patient consequence.

• Common Device Name: APPLIER, HEMOSTATIC, CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 12422487
• Report Number: 3005075853-2021-05249
• Device Sequence Number: 14331532
• Product Code: HBT
• UDI-Device Identifier: 10705036003854
• UDI-Public: 10705036003854
• Combination Product (Y/N): N
• PMA/510(K) Number: K830503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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: EL314
• Device Lot Number: FQGA12965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/03/2021
• Patient Sequence Number: 1