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

Catalog Number EL5ML

Device Problems Break (1069); Mechanical Jam (2983); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been 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.A manufacturing record evaluation was performed for the finished device lot number r4101h, and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Can you please clarify the event of "the clips got not positioned in closed position: they go out of the device improperly and stayed jammed at the end.After several attempts, the vessel has been damaged " did clips drop or eject out of the jaws of the device? did multiple clips feed into the jaws of the device at the same time? when "stayed jammed at the end", is this referring to clips in the jaws? were clips not able to be fired out of the jaws? did the jaws cut the vessel? or did the clips cut the vessel? how was the vessel repaired? were there any changes in the post-operative care of the patient due to the event? was there any patient consequence?.

Event Description

The clips got not positioned in closed position: they go out of the device improperly and stayed jammed at the end.After several attempts, the vessel has been damaged and the device has been replaced.Procedure: unknown.

Manufacturer Narrative

(b)(4).Batch # r94j25: device analysis: the analysis results found that the el5ml device was returned 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 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, upon disassembly the advancer was confirmed to be bent and 5 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.A manufacturing record evaluation was performed for the finished device batch r94j25 number, and no non-conformances were identified.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8424703
• MDR Text Key: 139075693
• Report Number: 3005075853-2019-17300
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: EL5ML
• Device Lot Number: R4101H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 03/22/2019
• Supplement Dates FDA Received: 04/12/2019
• Patient Sequence Number: 1