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	11/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Date of event: unknown, assumed first day of month that complaint was reported.Batch # unk.Additional information was requested and the following was obtained: "were there any consequences for the patient? there was no injury to any patient, as the device defect was identified in time." photo analysis: this is an analysis of a photo submitted to ethicon for evaluation.During the visual analysis the following was observed: the photo shows a device el314 with misaligned jaws.Unfortunately the photo does not provide enough evidence to determine the root cause.Based on the photo review, the event describe is confirmed, however no conclusion or root cause could be determined.Please refer to the device analysis for full analysis details and conclusion.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.The analysis results confirmed that the el314 device was returned nonfunctional as jaws were found to be misaligned; 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 misaligned 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.As part of ethicon¿s quality process all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot and no non-conformances were identified.
Event or Problem Description
It was reported that during an unknown procedure, the device was not working properly, when operating the handlebar so that the clip is closed.The tip does not seal completely, making it difficult to position the tip.No patient consequences.

• Common Device Name: APPLIER, HEMOSTATIC 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 16323700
• Report Number: 3005075853-2023-00843
• Device Sequence Number: 8098593
• Product Code: HBT
• UDI-Device Identifier: 10705036003854
• UDI-Public: 10705036003854
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2023

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: FQGA13633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown