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

Model Number EL5ML

Device Problems Failure to Advance (2524); Failure to Fire (2610)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # u93h0v.Investigation summary: the analysis results found that the el5ml device was returned with four spliced clips inside of jaws.In an attempt to replicate the reported event, the device was tested for functionality.Upon testing, the device was fired, and the clips did not advance into the jaw.The device was noted to have the tip of the advancer bent.The instrument was disassembled and upon disassembly, the advancer was confirmed to be bent and seven clips were found inside clip track.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.The reported complaint was confirmed.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.Please reference the instruction for use for more information.In addition, a photo was received for review.Upon visual inspection of photo, the following was observed: the photo shows a device from the jaws area with two spliced clips inside of jaws.Based on the photo, the event described is confirmed, however, no conclusion or root cause could be determined.Please refer to the device analysis for full analysis details and conclusion.A manufacturing record evaluation was performed for the finished device lot/batch number and no non-conformance's were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Hold for ab 10.22 it was reported that during a cholecystectomy, the clip stuck at the tip of the ligamax.There were no patient consequences.No additional information is available at this time.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10722372
• MDR Text Key: 212729246
• Report Number: 3005075853-2020-05499
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: U93H0V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1