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

Catalog Number	LX207
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Batch #: unknown.Additional information: a photo was received for review.Review is in progress and not yet completed.Upon completion of photo review, a supplemental medwatch will be sent.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.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.
Event or Problem Description
It was reported that during a thyroidectomy procedure, the formation of the clips was not optimal.The legs didn't close symmetrically, which leaves a small portion of the leg with no compression.Several clips had to be used to obtain hemostasis.The clip formation in clip applier was not optimal, the legs don¿t close symmetrically, which leaves a portion of the tissue with no compression.The portion with no compression was millimetric.There was no delay to procedure, surgery was successfully completed, and there was no patient consequence.
Additional Manufacturer Narrative
(b)(4).Date sent: 11/13/2020.H10=corrected data=d4; h8.D4: serial: the serial number was not provided; therefore, a manufacturing record evaluation could not be performed.H8: usage of device: reuse.
Additional Manufacturer Narrative
(b)(4).Date sent: 12/21/2020.H2: additional information received: upon visual inspection of one photo, the following was observed: the photo shows two clips with the tips not symmetrical; however, the clips can be seen properly closed.The instructions for use do contain the following: "caution: 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." based on the photos reviewed, the event described is confirmed, however no conclusion or root cause could be determined.Hands on device analysis may provide the additional evidence necessary to confirm the root cause of the reported event.

• Common Device Name: APPLIER, SURGICAL, CLIP
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 10836312
• Report Number: 3005075853-2020-05975
• Device Sequence Number: 3500908
• Product Code: GDO
• UDI-Device Identifier: 10705036012894
• UDI-Public: 10705036012894
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/26/2020

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: LX207
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 10/26/2020; 12/05/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 11/13/2020; 12/21/2020
• Patient Sequence Number: 1