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

Catalog Number EL5ML

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # r92304.Device analysis: 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.In an attempt to replicate the reported incident, the device was tested for functionality.Upon cycling, the instrument was noted to be empty and the lockout mechanism was found to be non-functional.In order to evaluate the device¿s internal components the instrument was disassembled.Upon disassembling of the device, the ratchet pawl and ratchet pawl spring were found out of position causing the anti-backup and lockout failures.No conclusion could be reached as to what may have caused this condition.The reported complaint was confirmed.The lot history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the packaging process.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.Additional information was requested and the following was obtained: what did the surgeon fell when grasping the trigger? the surgeon felt rough, but no information about what had the rough feel.Was the firing trigger difficult to pull back to fire the device? no information.Did the device complete the firing? no information.Was the clip formed completely? no information.Did the clip stay on the tissue? no information.No further information will be provided.

Event Description

It was reported that during a laparoscopic cholecystectomy, the surgeon felt something unusual when grasping the trigger.The device was used on the blood vessel.Another device was used to complete the case.There were no adverse consequences to the patient.

• 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: 7592790
• MDR Text Key: 111155526
• Report Number: 3005075853-2018-10540
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 20705036001840
• UDI-Public: 20705036001840
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: EL5ML
• Device Lot Number: R4027M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2018
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1