MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO LARGE APPLIER; LIGACLIP LARGE

Catalog Number	EL414
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Only event year known: 2018.Additional information was requested and the following was obtained: were the clips malformed, not closing? did the device not fire the clips? did the clips fall off the tissue? how was the procedure completed? response: bad formation means malformed.
Event or Problem Description
It was reported that during an unknown procedure, not clippling with the lt400 clip.There were no patient consequences.
Additional Manufacturer Narrative
(b)(4).Device analysis: the analysis results found that the el414 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 instrument was fully functional and conforming to our manufacturing requirements.The event described could not be confirmed as the device performed without any difficulties noted.The batch history records were reviewed and created 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: LIGACLIP LARGE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7614870
• Report Number: 3005075853-2018-10770
• Device Sequence Number: 2029312
• Product Code: HBT
• UDI-Device Identifier: 20705036003868
• UDI-Public: 20705036003868
• Combination Product (Y/N): N
• PMA/510(K) Number: K830503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

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: EL414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1