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

Catalog Number EL5ML

Device Problems Fitting Problem (2183); Failure to Form Staple (2579)

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

Event Type  malfunction  

Event Description

It was reported that during an unknown procedure, the device does not fit into the trocar so it was not activated and the clips came out open.It is unknown how the procedure was completed.There were no adverse consequences for the patient reported.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: did clips fall out of device unformed without device being fired? the first clip fall out while the doctor was trying to make the first shot.He could not continue because the device did not fire and it obstructed.The clip was open.The analysis results found that the el5ml device was returned in good visual condition.A bag with one unformed clip was received along with the instrument.In an attempt to replicate the reported incident, the device was tested for functionality.Upon testing, the device was cycled, fed and formed one clip as intended; the instrument locked out as intended.In addition, the device was inserted and removed through a test trocar without any difficulties.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 5MM
• 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: 4040439
• MDR Text Key: 4859724
• Report Number: 3005075853-2014-05967
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: EC
• 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
• Report Date: 07/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2018
• Device Catalogue Number: EL5ML
• Device Lot Number: K4DP4U
• Other Device ID Number: BATCH # K92H32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: K11LT