MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGAMAX-5MM ENDO CLIP APPLIER; CLIP, IMPLANTABLE

Catalog Number EL5ML

Device Problem Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Unknown, assumed 1st day of month that complaint was reported.Batch # p94j95 device analysis: the analysis results found that the el5ml device was received with no damage in the external components.In an attempt to replicate the reported event, the device was tested for functionality.Upon testing, the device was cycled and 7 conforming clips were fed and formed; then it was noted that the clips did not fully advance into the jaw.In order to evaluate the condition of the internal components, the device was disassembled.Upon disassembling, a 4 partially formed clips were found jammed inside the shaft leading to the found feeding issues and the tip of the advancer was found bent.A possible cause for the condition of bent advancer is actuating the device when the jaws are not clear of the trocar.Actuating the device with the jaws closed may bend the advancer.Please note that prior to loading a clip in the jaws, ensure that the demarcation between the jaws and the device shaft is past the end of the trocar cannula.Additionally, excessively applying a side load to the jaws, causing them to partially collapse could result in a clip malformation.The device jaws should be fully open and parallel upon initiating the firing of the device.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.The batch history record was reviewed and identified a partially formed clips eject or fall out of the device jaws defect related to the reported incident were found.When this occurs, our quality system documents the necessary actions to ensure final product quality.The final quality release criteria were met before this batch was released for distribution.In addition, no protocols or ncr related to the complaint, were found during the manufacturing process.

Event Description

Apparently when clipping the various ducts/vessels , during a laparoscopic cholecystectomy, the clips simply fell out when loaded.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• 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: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7506061
• MDR Text Key: 108184758
• Report Number: 3005075853-2018-09780
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 20705036001840
• UDI-Public: 20705036001840
• Combination Product (y/n): N
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2018
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1