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

Model Number LT200

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 05/02/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent: 5/31/2023.D4: batch # unk.A manufacturing record evaluation is pending.Additional information was requested and the following was obtained: please provide more details about statement: the titanium clips don't clip on tissue or vessels¿ did the device fire malformed clips? the clips did not clip as indicated, the reported item is a clip installed with a manual ligaclip applier.Did device fire scissored clips? it is not a staple that was used to fire the clips.Or did clip just not hold in tissue or vessel once placed? clip did not hold tissue/vessel.If other, please specify please confirm how many devices were involved in the procedure? 8 clips were used did the qty provided was the total of clips that failed? no, i returned the remaining clips.Was there any patient consequence as a result of the procedure being prolonged 45 mins? no.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, the titanium clips don't clip on tissue or vessels.Procedure delay of 45 minutes.

Manufacturer Narrative

(b)(4).Date sent: 7/31/2023.D4: batch # unk.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: "how many cartridges did the 8 clips that were used come from? were they all from the same cartridge or was 1 clip, from 8 different cartridges, used? what type of clip appliers were used with the clips? please provide product code if known." investigation summary: the product was returned to ethicon endo surgery for evaluation.Visual inspection and functional testing were conducted on the returned reload.Twenty-nine sterile reloads were returned.According to our analysis process, thirteen samples were taken randomly to be analyzed.Visual analysis of the returned sample revealed that lt200 reload (a) was received sterile with no apparent damage.The package was opened and tested for functionality with the test device.Upon functional testing of the device, the instrument loaded, retained, and deployed the 6 clips as intended.The clips were as intended and conform to our manufacturing requirements.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 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 device performed without any difficulties noted and no cartridge was returned for analysis.A manufacturing record evaluation was performed for the finished device lot number 767a38, 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: 17032290
• MDR Text Key: 316718142
• Report Number: 3005075853-2023-03620
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036012801
• UDI-Public: 10705036012801
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K830503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LT200
• Device Catalogue Number: LT200
• Device Lot Number: 767A38
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1