MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO MED/LG APPLIER

Catalog Number EL314

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Blood Loss (2597); No Code Available (3191)

Event Date 02/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.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.What were the indications for surgery? what was the manufacture or the product code of the clips used with the el314 device? was a lc800 loading base used with the cartridges that were used to load the clip applier? what was the vessel that these clips were place on? how many clips were placed on the patient side? were there any clip formation issues intra-operatively? if yes, please explain.How was the bleeding identified? can you please provide a time line of events? was the patient on anticoagulation therapy? did the patient have a clotting abnormality? was an autopsy performed? if yes, is the report available? would the surgeon be willing to speak with ethicon medical and engineering personnel? what was the cause of death? was an additional surgical procedure done? how was it known that the clip was loose?.

Event Description

Lap cholecystectomy.The ligaclip (code el314 ) for laparoscopy failed and the clip was loose causing postoperative bleeding.Action taken for procedure: reintervention but the patient died.

Manufacturer Narrative

(b)(4).The analysis results found that the el314 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 over suture.The instrument was fully functional and conforming.The batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment. the certificate records are accessible through external manufacturing. .

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: in this case there was not patient death, the patient had a bleeding after surgery but was taken again to surgery and the bleeding was solved.The report to the regulatory body said that there was no complications during the surgery but after the surgery it was a bleeding for potential fail of the clip due to low pressure of the clip over the cystic artery.What were the indications for surgery? r: cholecystectomy laparoscopic.What was the manufacture or the product code of the clips used with the el314 device? r: lt300.Was a lc800 loading base used with the cartridges that were used to load the clip applier? r: no, lt300.What was the vessel that these clips were place on? r: i don¿t understand the question.How many clips were placed on the patient side? r: 6 clips.Were there any clip formation issues intra-operatively? r: no.How was the bleeding identified? r: the health conditions of the patient deteriorated after the surgery.Can you please provide a time line of events? r: any.Was the patient on anticoagulation therapy?r: no.Did the patient have a clotting abnormality? r: no.Was an autopsy performed? r: no dead.Would the surgeon be willing to speak with ethicon medical and engineering personnel? r: yes.What was the cause of death? r: no dead.Was an additional surgical procedure done? r: any.How was it known that the clip was loose? r: no aplica ¿ not apply.Is the device available for return (yes or no)? r: yes.

• Type of Device: LIGACLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 7301108
• MDR Text Key: 101116491
• Report Number: 3005075853-2018-08237
• Device Sequence Number: 1
• Product Code: HBT
• Combination Product (y/n): N
• PMA/PMN Number: K830503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EL314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Date Manufacturer Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death