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

Model Number EL5ML

Device Problem Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event is 2019.Event day and event month were not provided.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain the following information: how much bleeding occurred? how was the bleeding controlled? was the patient given any blood products? was there any change in the procedure or post-op patient care changed due to the bleeding that occurred ? was there any patient consequence? if yes: please explain: how was the patient consequence resolved? to date no response has been provided.If the device or further details are received at a later date, a supplemental medwatch will be sent.

Event Description

It was reported that during an unknown procedure, the clips didn't close properly, being released during the procedure, which originated a hemorrhage of cystic artery.Patient consequence was not reported.

Manufacturer Narrative

(b)(4).Date sent: 1/17/2020.D4: batch # t93v40.Investigation summary: 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 and 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.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.H2: additional information received: how much bleeding occurred? information not available about the quantity, only know that have bled a lot.How was the bleeding controlled? applied pressure and more clips.Was the patient given any blood products? information not available.Was there any change in the procedure or post-op patient care changed due to the bleeding that occurred ? more surgery time.Was there any patient consequence? information not available.Attempts were made to obtain the information provided above and specific information could not be provided.If the further details are received at a later date, a supplemental medwatch will be sent.

• 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: 9506031
• MDR Text Key: 202578118
• Report Number: 3005075853-2019-24672
• 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
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2019
• Date Manufacturer Received: 01/06/2020
• Patient Sequence Number: 1