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

Model Number EL5ML

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #:unk.A manufacturing record evaluation was performed for the finished device and no non-conformances were identified.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 Description

It was reported that during a lap chole, after firing clips, the device jaws stayed shut.A new clip applier was opened and used to complete case with no issue.There were no patient consequences.

Manufacturer Narrative

(b)(4).Date sent: 1/31/2020.D4: batch # t94048.Investigation summary: the analysis results of the el5ml device found that it was received with no damage in the external components.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, it was noted that the clips did not fully advance into the jaw.In order to evaluate the condition of the internal components, the device was disassembled.Upon disassembling, the grey and white feedbar connectors were found to be separated and 14 clips were found inside clip track.Event could not be confirmed as the device opened and closed without any difficulties noted.No conclusion could be reached as to how the device became damaged.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances related to the reported complaint condition were identified.

• 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: 9495374
• MDR Text Key: 207314990
• Report Number: 3005075853-2019-24582
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2019

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: T94048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 01/31/2020
• Patient Sequence Number: 1