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

Catalog Number EL5ML

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # t9271p.Device analysis: 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 device was tested for functionality.Upon testing, it was noted that the clips did not fully advance into the jaw.The device was disassembled in order to evaluate the condition of the internal components and no anomalies were noted.In addition, 14 clips were found inside clip track.No conclusion could be reached as to what may have caused the feeding incident.The reported complaint was confirmed.A manufacturing record evaluation was performed for the finished device lot/batch number t9271p, and no non-conformances were identified.

Event Description

It was reported that during an unknown procedure, ligamax 5 was open.Tech noticed the device did not have any clips loaded.The surgery was not delayed due to the reported event.The procedure was successfully completed.There were no fragments generated.Second device was pulled to complete case.No patient consequences were reported.

• 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: 8603646
• MDR Text Key: 144992148
• Report Number: 3005075853-2019-19018
• 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,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: EL5ML
• Device Lot Number: T9271P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Date Manufacturer Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1