MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP* APPLIER W/MECH STOP; APPLIER, SURGICAL, CLIP

Catalog Number LX107

Device Problem Failure to Form Staple (2579)

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

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 12/15/2023.B3: unknown, assumed first day of month that complaint was reported.D4: batch # unk.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.

Event Description

It was reported that during an unknown procedure, when closing the clips, they weren't closing in the pattern/form they were supposed to.Some also appeared to be a bit crooked as well.No patient harm.

Manufacturer Narrative

(b)(4).Date sent: 1/25/2024.D4: batch # unk.Investigation summary: the product was returned to ethicon endo-surgery for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample revealed that the lx107 device was received with no apparent damage.In an attempt to replicate the reported incident, the device was tested for functionality.Upon functional testing of the device, the instrument loaded, retained, and deployed 6 clips as intended.The instrument was fully functional and conforming.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 the 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.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 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 no malformed clips were noted and performed without any difficulties noted.As part of ethicon endo surgery¿s quality process, all devices are manufactured, inspected, and released to approved specifications.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.

• Type of Device: APPLIER, SURGICAL, CLIP
• 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: 18335401
• MDR Text Key: 330604301
• Report Number: 3005075853-2023-09479
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036012856
• UDI-Public: 10705036012856
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: LX107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2021
• Type of Device Usage: Initial
• Patient Sequence Number: 1