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

Catalog Number EL5ML

Device Problems Bent (1059); Failure to Form Staple (2579); Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.

Event Description

It was reported that during a laparoscopic cholecystectomy procedure, ¿first attempt at firing, no clip.Second attempt showed distorted bent tip and malformed clip.The device was discarded and new device opened.There was a three minute delay to procedure.There was no adverse event to patient.¿.

Manufacturer Narrative

(b)(4).Batch # p91h4h.The analysis results found that the el5ml device was returned with no damage in the external components; upon visual inspection, two clips were noted to be jammed inside the shaft.The clips were removed in order to perform functional testing.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 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 was found damage causing the lockout failures.The jammed clip may have caused the device to not fire the clips properly or at all; however, cause not determined could be reached as to what may have caused the clip jamming.No conclusion could be reached as to what may have caused the reported incident.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.

• Brand Name: LIGAMAX ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• Manufacturer Contact: milton garrett ; 4545 creek road ml 120a; cincinnati, OH 45242 ; 5133378865
• MDR Report Key: 6724803
• MDR Text Key: 80564906
• Report Number: 3005075853-2017-03702
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1