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

Catalog Number EL5ML

Device Problems Failure to Form Staple (2579); Activation, Positioning or Separation Problem (2906); Ejection Problem (4009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformance's 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 right thoracotomy, the doctor was trying to ligate peripheral vessels and encountered the following issues with the clip applier.Clips were scissoring, clips were falling out of the device, and clips were not deploying.The doctor continued to use device to complete the procedure.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Batch # r95669.Investigation summary: the analysis results found that the el5ml device was received with no damage in the external components.In addition, the tyvek was returned along with the instrument.Upon cycling, the instrument was noted to be empty and locked out.The instrument is designed to lock out after all the clips have been fired; therefore a potential cause of the customer reported experience is the firing of all of the clips and the instrument "will not fire" (activation of the lock out mechanism).The instrument has an orange indicator that appears on the top of the handle as a reference for the user as to the quantity of clips remaining.In order to evaluate the condition of the internal components of the device, it was disassembled.Upon disassembling, no anomalies were found.No conclusion could be reached as to what may have caused the event reported.The reported complaint was confirmed.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances 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: 9156300
• MDR Text Key: 196199604
• Report Number: 3005075853-2019-22573
• 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: 09/12/2019

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 Expiration Date: 11/30/2023
• Device Catalogue Number: EL5ML
• Device Lot Number: R95669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 10/04/2019
• Supplement Dates FDA Received: 10/09/2019
• Patient Sequence Number: 1