MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGAMAX-5MM ENDO CLIP APPLIER; CLIP, IMPLANTABLE

Model Number EL5ML

Device Problem Failure to Form Staple (2579)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number and no non-conformances were identified.Attempts are being made to obtain the following additional information and the device: was there any patient consequence? if yes: please explain.How was the patient consequence resolved? to date no response has been received and device analysis has been completed.Follow-up activity closed.

Event Description

It was reported that during a laparoscopic cholecystectomy and intraoperative cholangiogram, the device was not clipping properly.It didn¿t close the clips properly.Another device was opened and used.There was no delay to procedure and patient consequence was not reported.

Manufacturer Narrative

(b)(4).Date sent: 1/29/2020.D4: batch # t93x04.Investigation summary the analysis results found that the el5ml device was returned with no damage in the external components.In an attempt to replicate the reported incident, the instrument was tested for functionality.During the analysis, the device was cycled and it fed and formed 11 conforming clips.The event described could not be confirmed as the device performed without any difficulties noted.The reported complaint could not be confirmed.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.

Manufacturer Narrative

(b)(4).Additional information obtained: there was a delay in completion of the procedure.The case was completed another device was opened this was said by dr and nurse.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9506350
• MDR Text Key: 191870481
• Report Number: 3005075853-2019-24683
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2019

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
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Device Lot Number: T94R7E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Manufacturer Received: 12/04/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/08/2020; 02/06/2020
• Supplement Dates FDA Received: 01/29/2020; 02/07/2020
• Patient Sequence Number: 1