MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*ENDO MED/LG APPLIER; APPLIER, HEMOSTATIC CLIOP

Catalog Number	EL314
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pc-(b)(4).Batch # unk.Attempts are being 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.The device history records were reviewed and certed by external manufacturing that the manufacturing criteria were met prior to the release of the equipment.The certificate records are accessible through external manufacturing.
Event or Problem Description
It was reported that during a laparoscopic cholecystectomy, the device wasn't working properly and clips were getting loosened or they fell off when applied ("tried checking it inside ot").The clips were not holding tissue/vessel.There was no patient consequence as they had another applier of some other company through which they completed the case.
Additional Manufacturer Narrative
(b)(4).Date sent: 3/21/2022.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 el314 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 to our manufacturing requirements.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.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 by the handle and trigger and 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 trigger tension to hold the clip in the applier jaws.The sequence for rotation of the applier shaft is as follows: loosen the rotation knob by turning it clockwise until a click is heard.Rotate the shaft to the desired position.Tighten the rotation knob completely by turning it counterclockwise.Position the clip around the tubular structure to be ligated.Apply enough 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.The batch history records were reviewed and certed by external manufacturing that the manufacturing criteria was met prior to the release of the equipment.  the certificate records are accessible through external manufacturing. .

• Common Device Name: APPLIER, HEMOSTATIC CLIOP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 13162404
• Report Number: 3005075853-2022-00030
• Device Sequence Number: 11757075
• Product Code: HBT
• UDI-Device Identifier: 10705036003854
• UDI-Public: 10705036003854
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 03/21/2022

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: EL314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 03/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown