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

Catalog Number MCM20

Device Problem Difficult to Open or Close (2921)

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

Event Date 03/20/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # r94u3t.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 15 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 r94u3t number, 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.What is meant by no closing properly? what was the shape of the clip(s)? how were the clips that did not close properly addressed intra-operatively in the initial procedure? what vessels was the device used on? what was the name of the procedure? how long after the procedure was the bleeding identified and how was the bleeding addressed? during the re-op was improper clip formation identified? if yes, please provide more detail.What is the current patient status?.

Event Description

It was reported that the device released faulty clips which were found not closed properly.This contributed to post-operative bleeding and patient required further surgery to stop the bleeding.Patient bled in the early morning of day one post -op and was taken to theatre.We found displaced/malfunctioning clips.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: i have no additional information i can provide or add.All relevant information was provided to the best of my knowledge from what i had received at that time and there is no more forthcoming information i possess.If you seek further information, please contact (b)(6).He will be able to provide 100% direct and accurate information you seek.Additional information request has been sent directly to (b)(6).To current date, no response has been received.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was obtained: what is meant by no closing properly? what was the shape of the clip(s)? the shape of the clips was as in its origin but partially closed (both branches remained parallel with a reduced gap between them compared to its original position before being delivered.How were the clips that did not close properly addressed intra-operatively in the initial procedure? the identified faulty ones were replaced by vicryl 2/0 only.What vessels was the device used on? clips were used on arteries from 1 mm to 5 mm caliber and on veins of the same caliber.What was the name of the procedure? hemithyroidectomy.How long after the procedure was the bleeding identified and how was the bleeding addressed? the bleeding was identified 10 hours after the procedure.Patient needed to go back to theatre for a second operation.During the re-op was improper clip formation identified? if yes, please provide more detail.Yes, two or three opened clips as described above were retrieved from the area of bleeding and given to the scrub nurse as a proof.Patient stayed in itu for 7-10 day and then discharged from hospital.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8697643
• MDR Text Key: 147996291
• Report Number: 3005075853-2019-19718
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: MCM20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Date Manufacturer Received: 09/17/2019
• Patient Sequence Number: 1