MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*EXTRA TITANIUM CLIPS; CLIP, IMPLANTABLE

Model Number LT300

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Renal Failure (2041); Blood Loss (2597); Not Applicable (3189); No Code Available (3191)

Event Date 08/21/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 9/23/2020, batch # unk.The serial number was not provided; therefore, a manufacturing record evaluation could not be performed.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a lap sigma procedure, blood loss occurred after the surgery because two titanium clips detached from the arteria mesenterica inf.Thus requiring emergency surgery.Two clips were originally placed on the patient side of ima, there were no clip formation issues during the initial procedure, and the clip appliers were inspected prior to use in the procedure to insure proper alignment.Patient lies in intensive care.During the first surgery there were no abnormalities with the clip forceps or the clips.

Manufacturer Narrative

(b)(4).Date sent: 10/19/2020 h2: additional information received: what vessel was clamped during the initial procedure, the ima or a branch? ima what was the size of the vessel being clamped? 3-4mm how long was it after the initial procedure when the bleeding was identified? ca.3 hours what was the approximate amount of blood loss? ca 2 liter was a blood transfusion required? yes how was the patient treated during reoperation? stitching the ami, the clips were both what is patient¿s current status? transfer to geriatric rehabilitation, acute renal failure, currently undergoing dialysis.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10575010
• MDR Text Key: 208318326
• Report Number: 3005075853-2020-04859
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012825
• UDI-Public: 10705036012825
• 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
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LT300
• Device Catalogue Number: LT300
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Patient Sequence Number: 1
• Treatment: SURGICAL CLIP APPLIER, REUSABLE
• Patient Outcome(s): Hospitalization; Required Intervention