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

Model Number EL5ML

Device Problem Failure to Fire (2610)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch #: u94m4w.Component code: mechanical (g04).Investigation summary: the analysis results found that the el5ml device 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, the instrument was cycled and it fed and formed ten conforming clips; however, the lockout mechanism was non-functional.In order to evaluate the condition of the internal components, the device was disassembled, and the ratchet pawl was found out of position causing the failure of the lockout feature.The device performed without any difficulties noted.No conclusion could be reached as to what may have caused this condition.It should be noted that as part of our quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.A manufacturing record evaluation was performed for the finished device lot/batch number, and no non-conformances were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a laparoscopic cholecystectomy, the clip applier didn¿t contain any clips.They fired it three times and no clips were deployed.Surgery was delayed two minutes due to this reported event.They opened a second clip applier to complete the case.No patient complications.

Manufacturer Narrative

(b)(4).Date sent: 12/14/2020.Added component code to f10: component code: others (g07) and added component code h6: others (g07).H6: added investigation findings: no device problem found (g19).H6: investigation conclusion: updated to cause not established (d15) (and remove d1102, unintended use error caused or contributed to event.Investigation summary (updated to add the following): though the device performed without any difficulties noted, please reference the instructions for use that contains the following: "caution: ensure that a clip is in the jaws.Position the jaws so that the clip completely surrounds the vessel to be ligated.Fully squeeze the handles together until they stop.As the handles are squeezed, the clip closes and occludes the vessel or tubular structure.Fully release the handles to return the instrument to its original open position.The next clip is automatically advanced.Inspect the jaws after each clip application to ensure the presence of a new clip before applying the next clip.Repeat steps as necessary to continue ligation of tissue.For optimal performance, periodically clean the instrument during the procedure by submerging the jaw and distal end of the applier shaft in saline.".

• 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: 10996728
• MDR Text Key: 221286345
• Report Number: 3005075853-2020-06751
• 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
• Type of Report: Initial,Followup
• Report Date: 11/23/2020

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: U94M4W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/12/2020
• Supplement Dates Manufacturer Received: 12/12/2020
• Supplement Dates FDA Received: 12/14/2020
• Patient Sequence Number: 1