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

Catalog Number EL5ML

Device Problems Failure to Form Staple (2579); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # unk.Attempts have been 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.A manufacturing record evaluation was performed for the finished device lot number t9225u, and no non-conformances were identified.

Event Description

It was reported that during an unknown procedure, when clipping, it made noise and malformation.Extra power was needed as unusual.

Manufacturer Narrative

(b)(4).Batch #: r94m14.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 2 conforming clips.Upon testing, the jaws opened and closed without any difficulties.In addition, the device locked out as intended and no noise was heard.No conclusion could be reached as to what may have caused the reported incident.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.

• Brand Name: LIGAMAX-5 5MM ENDOSCOPIC MULTIPLE CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 8543646
• MDR Text Key: 142937439
• Report Number: 3005075853-2019-18376
• 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,literature
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: EL5ML
• Device Lot Number: T9225U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Date Manufacturer Received: 08/30/2019
• Patient Sequence Number: 1