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

Catalog Number LX110

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

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 4/11/2024 b3: unknown, assumed first day of month that complaint was reported d4: batch # unk additional information was requested and the following was obtained: "how did device not work? some fell out , some scissored did device jammed (not fire clips)? jamming wasn¿t a problem, clips fell out did device not feed clips? manual did device drop or eject clips? yes did device sideways feed clips? no did device fire malformed clips? yes did device fire scissored clips? yes" an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.

Event Description

It was reported that during an unknown procedure, the clips are not clipping properly and are not effective.No patient harm.

Manufacturer Narrative

(b)(4).Date sent: 6/17/2024.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 lx110 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.As part of ethicon endo surgery¿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 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 or scissored clips were observed and the device performed without any difficulties noted.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.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 ; * 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: 19091846
• MDR Text Key: 340689381
• Report Number: 3005075853-2024-02837
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036012863
• UDI-Public: 10705036012863
• 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
• Report Date: 04/11/2024

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: LX110
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1