MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. "LIGACLIP* APPLIER 27,5 MEDIUM"; APPLIER, SURGICAL, CLIP

Catalog Number	LC210
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Form Staple (2579); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4); batch #: unk.Date of event is 2020.Event day and event month were not reported.The serial number was not provided, therefore, the manufacturing record evaluation could not be performed.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.
Event or Problem Description
It was reported that during an unknown procedure, the clip applier didn't apply proper clips.The jaws were spoiled.User reported the clips are not broken, the clip applier didn't hold the clips.Clip applier jaws were broken so they didn't hold the clips and because the clip applier jaws were broken, it didn't make the clips hold the vein, or tissue.It is unknown how procedure was completed.There was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/13/2021.H6: component code: mechanical (g04).Investigation summary: the analysis results confirmed that the lc210 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.It should be noted that as part of our quality process all  devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.The serial number 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. .

• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11033519
• Report Number: 3005075853-2020-06970
• Device Sequence Number: 13769481
• Product Code: GDO
• UDI-Device Identifier: 10705036012900
• UDI-Public: 10705036012900
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: LC210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 01/13/2021
• Patient Sequence Number: 1