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

Catalog Number	EL314
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Date of event is 2020.Event day and event month were not reported.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain the following information and the device.To date, no response has been provided and no device has been received.If the device or further details are received at a later date, a supplemental medwatch will be sent: please clarify how the ¿impossibility of securing the clip by the device¿.Was the device unable to load the clip in the applier? or, clip does not stay in place or falls off after being applied on a vessel or tissue? the batch and/or lot number you provided, fqga12561, is invalid.Do you have the correct six digit/character batch and/or lot number for the el314 device? please provide the status of the device(s) as it has not been received for analysis.
Event or Problem Description
It was reported that during an unknown procedure, there was a clipper failure.It was impossible to secure the clip by the device.There was not delay to procedure, procedure was successfully completed, and there was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/14/2020.D4: serial #: (b)(6).F10 and h6: component code: others (g07).Investigation summary: the analysis results found 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 six clips as intended.The instrument was fully functional and conforming to our manufacturing requirements.The event described could not be confirmed as the device performed without any difficulties noted.Although there is no direct evidence of use error, 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." 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.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.The device 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 CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10839408
• Report Number: 3005075853-2020-06002
• Device Sequence Number: 14328044
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

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
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 11/19/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/15/2020
• Patient Sequence Number: 1