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

Model Number LT100

Device Problems Unintended Ejection (1234); Failure to Form Staple (2579); No Apparent Adverse Event (3189)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/19/2023

Event Type  Injury  

Event Description

It was reported that during a cabg procedure, clips are coming out of the cartridges.When applying clips on vessels, clips are falling out of applicator.Some clips are not getting applied on artery or vein, causing bleeding and oozing.Procedure delayed 120 minutes.

Manufacturer Narrative

(b)(4).Date sent: 7/12/2023.D4: batch #: unk.A manufacturing record evaluation is pending.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: "please clarify what is meant by ¿clips are coming out from cartridges.¿ are three separate alleged issues being reported? did clips fall out of cartridge, device jaw, and off of vessels? how was bleeding controlled? was procedure modified due to bleeding/oozing? did patient require transfusion? if yes, how much blood did they receive? did the patient require modified post op care due to bleeding/oozing? what is current patient status? what is surgeons experience with this device? did the clips appear to be malformed? what device was used with the clips? please provide serial number if possible.Is the lc800 base being used when loading the clips? does the surgeon believe that there is an alleged deficiency with the ethicon device that may have caused or contributed to the leak?" 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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 8/2/2023.D4: batch # unknown.An analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance were identified.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 17311616
• MDR Text Key: 318924789
• Report Number: 3005075853-2023-04874
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012788
• UDI-Public: 10705036012788
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K830503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: LT100
• Device Catalogue Number: LT100
• Device Lot Number: 745A93
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other