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

Catalog Number	LX207
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch # unk.Date of event is (b)(6) 2019.Event day was not provided.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being 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 a pediatric thoracic procedure, the surgeon did an echocardiogram and found that the clip was scissored where he had applied it.According to the customer the clip did what is was supposed to do and there were no patient consequences, but the surgeon noticed that is was scissored.
Additional Manufacturer Narrative
(b)(4).Date sent: 1/10/2020.Investigation summary: the analysis results found that the lx207 device was received with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon functional testing of the device, the instrument loaded, retained, and deployed 6 clips as intended.The device was fully functional and conforming.The event described could not be confirmed as the device performed without any difficulties noted.The batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.

• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9454823
• Report Number: 3005075853-2019-24201
• Device Sequence Number: 16238112
• Product Code: GDO
• UDI-Device Identifier: 10705036012894
• UDI-Public: 10705036012894
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 11/20/2019

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: LX207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 01/10/2020
• Patient Sequence Number: 1