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

Catalog Number	LX210
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: the analysis results confirmed that the lx210 device was returned non-functional, 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 and 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 device history records were reviewed and certed by external manufacturing that the manufacturing criteria were 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, there was a "broken applier, single clip medium, white 10 ½¿ (lx 210)".There was no patient involvement or consequence.No additional information is available at this time.

• Common Device Name: APPLIER, SURGICAL CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 10370100
• Report Number: 3005075853-2020-03984
• Device Sequence Number: 19070300
• Product Code: GDO
• UDI-Device Identifier: 10705036012900
• UDI-Public: 10705036012900
• Combination Product (Y/N): N
• Initial Reporter State: CT
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2020

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: LX210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/05/2020
• Patient Sequence Number: 1