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

Catalog Number MCS20

Device Problems Component Falling (1105); Failure to Form Staple (2579)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 11/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Information asked for but unknown or not provided during initial contact.When additional information is received and/or the device analysis has been completed, a supplemental medwatch will be sent.

Event Description

It was reported that during a thyroidectomy procedure, this was the third device used from the same box on the same patient.Several clips did not close securely and several more fell off once placed.Clips were retrieved and a new device was opened.There was a delay of five to ten minutes.The patient outcome is satisfactory.There were no adverse consequences for the patient reported.

• Brand Name: LIGACLIP CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 5221634
• MDR Text Key: 31377307
• Report Number: 3005075853-2015-07344
• Device Sequence Number: 1
• Product Code: GDO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K820837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MCS20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1