MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP* APPLIER W/MECH STOP

Catalog Number	LX105
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Photo analysis: this is an analysis of a photo submitted to ethicon endo surgery for review.During the visual analysis the following was observed: the photo shows a product lx105 code device apparently in good condition, without bodily fluids.Based on the set of photos review, the event describe is not confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.Because the instrument was not returned our evaluation is limited.We value the opportunity to fully analyze the instrument upon its return.As part of ethicon endo surgery quality process all devices are manufactured, inspected, and released to approved specifications.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that during an unknown procedure the clipper does not fully close the clip.The procedure was successfully completed and there were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Date sent: 8/12/2022.Investigation summary the product was returned to ethicon endo surgery for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the returned sample determined that the lx105 device was returned nonfunctional as the jaws were misaligned; therefore, the clips could not be loaded into the jaws.No conclusion could be reached as to what may have caused the found condition of jaws.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 endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.

• Common Device Name: LIGACLIP* APPLIER W/MECH STOP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo
• MDR Report Key: 14647300
• Report Number: 3005075853-2022-03736
• Device Sequence Number: 12205177
• Product Code: GDO
• UDI-Device Identifier: 10705036012849
• UDI-Public: 10705036012849
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2022

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: LX105
• Device Lot Number: FQGA12945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/30/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 06/09/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown