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

Catalog Number	LT200
Medical Device Problem Codes	Failure to Form Staple (2579); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unknown procedure, staples tack together at an angle and the white housings in which the staples are inserted are coming apart.No patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/19/2024 b3: unknown, assumed first day of month that complaint was reported d4: batch # unk investigation summary the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned cartridges.Visual analysis of the returned sample revealed that 17 lt200 cartridges were received sterile with no apparent damage and six clips loaded per sample.The cartridges were tested for functionality and a drop test was performed on each cartridge and no loose clips were noted.The cartridges were tested for functionality with the test device.Upon functional testing, the instrument loaded, retained, and deployed the 6 clips per sample as intended.The clips were formed as intended and conforming to our manufacturing requirements.As part of ethicon's quality process, all devices are manufactured, inspected, and released to approved specifications.Although no conclusion could be reached on the cause of the reported event, the instructions for use do contain the following caution: select the appropriate size ligaclip extra ligating clip cartridge and corresponding clip applier.With the cartridge slots facing away from the base, insert the cartridge into one of the channel openings of the lc800 stainless steel cartridge base.Ensure that the cartridge is past the channel opening and securely held in place.Grasp the applier in the box lock area using pencil grip technique.If using an endoscopic applier, grasp the applier by the handle and trigger.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.Keeping the applier jaws perpendicular to the surface of the cartridge, retract the applier from the cartridge.The clip will be securely held in the applier jaws.It is not necessary to maintain ring or trigger tension to hold the clip in the applier jaws.Position the clip around the tubular structure to be ligated.Apply sufficient force to fully close the applier to assure that the clip is satisfactorily placed and secured.The event described could not be confirmed as the cartridges were performed without any difficulties noted.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.

• Common Device Name: 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 20727009
• Report Number: 3005075853-2024-08789
• Device Sequence Number: 8395934
• Product Code: FZP
• UDI-Device Identifier: 10705036012801
• UDI-Public: (01)10705036012801(17)290430(10)996C43
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K830503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: LT200
• Device Lot Number: 996C43
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown