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

Model Number LT400

Device Problem No Apparent Adverse Event (3189)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/01/2022

Event Type  malfunction  

Event Description

It was reported that post op to a laparoscopic cholecystectomy the patient was found to have 3,000 ml of blood in the abdomen.The patient was reoperated on and it was discovered the clips did not close in the middle.This was corrected and four units of blood were given and the patient is improving.

Manufacturer Narrative

(b)(4).Batch#: unknown.Manufacturing records of this lot and batch could not be completed as the lot and batch numbers were not provided.Investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection was conducted on the returned reload.Visual analysis of the returned sample revealed that lt400 clips were returned without reload and along with an unknown retainer.4 loose clips properly formed and 9 loose no completely closed were received.In order to replicate the reported event, test lt400 clips were fired with an lc300 device product code and the clips were malformed in the same form than the clips returned.In addition, it was noted that the properly formed clips returned were smaller than the malformed clips.It is possible that this clips are lt200 clips product code.The event reported was confirmed and it is related to improper use of the device.Select the appropriate size ligaclip extra ligating clip cartridge and corresponding clip applier.Please reference the instruction for use for more information.As part of ethicon endo surgery¿s quality process all devices are manufactured, inspected, and released to approved specifications.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15474083
• MDR Text Key: 303744034
• Report Number: 3005075853-2022-06326
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012832
• UDI-Public: 10705036012832
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LT400
• Device Catalogue Number: LT400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1