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

Catalog Number LT200

Device Problems Unintended Ejection (1234); Failure to Form Staple (2579)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2023

Event Type  malfunction  

Event Description

It was reported that during a vasectomy procedure, the clips sometimes formed an "s" already in the magazine, sometimes the clips just fell out of the magazine.In general the clips acted strange and not like they are used to.Replaced magazine to continue procedure.No patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 11/7/2023.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: 12/15/2023.D4: batch # unk.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned cartridge.Visual analysis of the returned samples revealed that 17 lt200 cartridges were received sterile with no apparent damage and 6 clips loaded each.Only 13 samples (a-m) were opened.The cartridges were tested for functionality and a drop test was performed on the reloads and no loose clips were noted.The cartridges were tested for functionality with the test device.Upon functional testing of the clips, the instrument loaded, retained, and deployed six clips per sample as intended.The clips were as intended and conforms to our manufacturing requirements.The event described could not be confirmed as the clips performed without any difficulties noted.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number 410c54, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Date sent: 1/17/2024.D4: batch # unk.Investigation summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned cartridge.Visual analysis of the returned samples revealed that 17 lt200 cartridges were received sterile with no apparent damage and 6 clips loaded each.Only 13 samples (a-m) were opened.The cartridges were tested for functionality and a drop test was performed on the reloads and no loose clips were noted.The cartridges were tested for functionality with the test device.Upon functional testing of the clips, the instrument loaded, retained, and deployed six clips per sample as intended.The clips were as intended and conforms to our manufacturing requirements.The event described could not be confirmed as the clips performed without any difficulties noted.Additionally, one photo was provided and it showed the base of the cartridge separated from the body along with two malformed clips and one unformed clip.It is recommended to insert the clip cartridge into the loading base.Grasp the applier in the box lock area using pencil grip technique.Insert the jaws of the instrument into the individual cartridge slot, making sure the tips of the applier are perpendicular to the surface of the cartridge.Insert the applier until it stops.Do not force the applier.It should enter and withdraw from the cartridge smoothly.Please reference the instruction for use for more information.As part of ethicon¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device lot number 410c54, and no non-conformances were identified.

• 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: 18086657
• MDR Text Key: 327743672
• Report Number: 3005075853-2023-08252
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012801
• UDI-Public: 10705036012801
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K830503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LT200
• Device Lot Number: 410C54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1