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

Catalog Number EL5ML

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Only event year known: 2019.Batch # r9538g.Device analysis: the analysis results found that the el5ml device was returned with no damage in the external components and a plastic bag with a scissored clip inside.In addition, the tyvek was returned along with the instrument.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 8 conforming clips.Upon testing, the jaws open and close without any difficulties.In addition, the device locked out as intended.No conclusion could be reached as to what may have caused the reported incident.A manufacturing record evaluation was performed for the finished device batch number r9538g, and no non-conformances related to the reported complaint condition were identified.

Event Description

It was reported that while clipping an artery in lap chole, the clip bent causing ends to cross over.No patient injury.New device opened.There was no delay in the surgery.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 8432447
• MDR Text Key: 139312358
• Report Number: 3005075853-2019-17333
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2019

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: R9538G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Manufacturer Received: 02/21/2019
• Initial Date FDA Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1