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

Catalog Number EL5ML

Device Problems Failure to Form Staple (2579); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2014

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic procedure, scissoring occurred 3 times in a row.The clip did not fall into the patient.Another device was used to complete the case.There were no adverse consequences to the patient.The target tissue was not damaged.There were no anomalies in grasping and releasing the trigger.There was no unexpected noise at firing.There was no torquing or twisting of the device present at the time of firing.No clips or hard materials had been clamped with the device.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Additional information: the analysis results found that the el5ml device was returned in good visual condition.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled, fed, and formed the remaining clips as intended.In order to confirm the clips were within manufacturing specifications, the clips were evaluated using a tool that is designed to determine proper formation.In addition the device locked out as intended.No conclusion could be reached as to what may have caused the reported incident.The batch record was reviewed and no anomalies were noted during the manufacturing process.

• Brand Name: LIGAMAX CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo PR 0096 9
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 0096 9
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4044927
• MDR Text Key: 4904926
• Report Number: 3005075853-2014-06023
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2019
• Device Catalogue Number: EL5ML
• Other Device ID Number: BATCH # L91987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1