MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP MCA MED; CLIP, IMPLANTABLE

Catalog Number MCM20

Device Problems Sticking (1597); Noise, Audible (3273)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Date 07/13/2016

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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this batch/lot.Additional information was requested and the following was obtained: how was the stuck device removed from hepatic vessel? trying to remove it slowly.Was the user ever able to open the stuck device during the procedure? yes but after.Some useless attempts to operate it.When you say the hepatic vessel ruptured, did the jaws of the device tear the hepatic vessel? yes.How much bleeding occurred with the ruptured hepatic vessel (please quantify the amount of bleeding in ccs)? ni.The patient's hematocrit dropped from 33 to 19.Was bleeding controlled during this same procedure? yes.How was the bleeding controlled? by using a prolene suture.Was the patient given any blood products? 1 lt.Blood.Was there any change to the procedure or post-op patient care? no.What is the patients current status? post op normal.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 liver resection was being performed? what were the indications for surgery? what exact vessel were the devices being fired on? vein or artery? what was the size of the vessel? what troubleshooting steps were taken to open the devices once they became locked on tissue? what firing did this occur on with each device? were three separate tears and repairs required on the same vessel?.

Event Description

It was reported that during right liver resection, in the clipping phase, the device got stuck and caused the rupture of the hepatic vessel.The operator refers to have heard a click.

Manufacturer Narrative

(b)(4).Batch # n90y93.The analysis results found that the mcm20 device was received with a clip in the jaws.The instrument was noted to have the jaws open.In an attempt to replicate the event reported, the device was tested for functionality it was noted to have issues holding the clip on the jaw.The partially formed clip was a result of testing to determine the functionality of the anti-backup feature.Upon testing, the device was cycled and it fed and formed the remaining 11 clips as intended.In order to evaluate the condition of the internal components, the device was disassembled and the anti-backup lever was noted to be worn out.No conclusion could be reached as to what may have caused the reported incident.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: LIGACLIP MCA MED
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5890225
• MDR Text Key: 52567945
• Report Number: 3005075853-2016-04692
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K820837
• 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,Followup
• Report Date: 07/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: MCM20
• Device Lot Number: N4LE4R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2016
• 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
• Patient Outcome(s): Required Intervention