MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP® MCA MULTIPLE CLIP APPLIER / 29.2 CM, 20 MEDIUM TITANIUM CLIPS; CLIP, IMPLANTABLE

Catalog Number MCM20

Device Problems Complete Blockage (1094); Difficult to Open or Close (2921)

Patient Problem No Code Available (3191)

Event Date 10/11/2018

Event Type  Injury  

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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.Additional information was requested, and the following information was received: was there any patient consequence? no.There was no patient consequence, only a risk of hemorrhage related to the dysfunction of the device.A second procedure was necessary.Indeed, after the first procedure, the patient presented a hematoma and the surgeon had to perform a second hemostasis.A clip was found "into" the patient's neck.It was not well closed.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.Was there any malformation of clips in the 1st procedure? if yes, how was this addressed? how long after the 1st procedure was the hematoma diagnosed? can you please describe more about the malformed clip? please explain what is meant by ¿clip was not closed well¿.What was the surgical procedure (it was reported as a pelvic surgery, but a clip was found in the neck)? what is the current patient status?.

Event Description

During the procedure, the device was blocked at the first use: difficulty opening the grasper.A few minutes later, difficulty to position the clip for making a correct haemostasis.Momentary interruption of hemostasis.Risk of hemorrhage and patient injury.Procedure: pelvic surgery.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: please explain what is meant by ¿clip was not closed well¿? the clips did not have a proper sharp to perform a correct hemostasis.What was the surgical procedure (it was reported as a pelvic surgery, but a clip was found in the neck)? in fact, the correct procedure name is a pelvi-mandibulectomy.Was there any malformation of clips in the 1st procedure? unknown, difficulty during the opening of the device.If yes, how was this addressed? use another device.How long after the 1st procedure was the hematoma diagnosed? unknown.What is the current patient status? the patient goes well.

Manufacturer Narrative

(b)(4).Batch # r93n0x.Device analysis: the analysis results found that the mcm20 device was returned with no damage in the external components. in an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled and it fed and formed the remaining 3 clips as intended.As the device was found to be fully functional, it could not be determined what may have caused the reported incident.No conclusion could be reached as to what may have caused the reported incident.The reported complaint could not be confirmed.A manufacturing record evaluation was performed for the finished device batch r93n0x number, and no non-conformances were identified.

• Brand Name: LIGACLIP® MCA MULTIPLE CLIP APPLIER / 29.2 CM, 20 MEDIUM TITANIUM CLIPS
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8125412
• MDR Text Key: 129077192
• Report Number: 3005075853-2018-14783
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002475
• UDI-Public: 10705036002475
• Combination Product (y/n): N
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: MCM20
• Device Lot Number: R40M4Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Date Manufacturer Received: 03/26/2019
• Patient Sequence Number: 1
• Patient Age: 56 YR