MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP*MCA MED APPLIER; CLIP, IMPLANTABLE

Model Number MCM20

Device Problems Mechanical Problem (1384); Failure to Form Staple (2579); Failure to Fire (2610)

Patient Problem Swelling/ Edema (4577)

Event Date 03/22/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch #: unknown.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain additional information.To date, no additional information has been received.If further details are received at a later date, a supplemental medwatch will be sent: did the device issue(s) that occurred include: "not firing, firing out two clips at a time, on vessel security (clip not holding on vessel), clip malformation, and clips transecting vessels?" please report all clip issues from the above list that occurred for this complaint device intra-op and post-op.What was the approximate blood loss? was a transfusion required?.

Event Description

It was reported that during a neck dissection they noticed swelling at incision site after having closed the patient.They reopened the incision and the clips had fallen off of a vessel.They reclipped the vessel to complete the case.The patient is doing fine.

Manufacturer Narrative

(b)(4).H2: additional information received: additional information received from rep device issues include would not fire, fired two, and 2-3 single clips did not hold.Blood loss was minimal, they recognized it before they sent the patient to the recovery unit and addressed the bleeding.No transfusion was required.Patient is okay.

• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 11697720
• MDR Text Key: 260314913
• Report Number: 3005075853-2021-02139
• Device Sequence Number: 1
• Product Code: GDO
• UDI-Device Identifier: 10705036002475
• UDI-Public: 10705036002475
• Combination Product (y/n): N
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MCM20
• Device Catalogue Number: MCM20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention