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

Catalog Number EL5ML

Device Problem Bent (1059)

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

Event Date 10/06/2014

Event Type  malfunction  

Event Description

It was reported that during a sleeve gastrectomy procedure the shaft was bent.Unknown what firing the bent shaft was noticed.A second device was pulled to complete the procedure with no patient consequence.

Manufacturer Narrative

(b)(4).The analysis results found that the el5ml device was returned with the shaft bent at the rotation knob area.Due to the returned condition of the device, no further testing could be performed.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.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 00969
• 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: 4248457
• MDR Text Key: 4987329
• Report Number: 3005075853-2014-07891
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2014

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 Expiration Date: 07/06/2019
• Device Catalogue Number: EL5ML
• Device Lot Number: L4EZ9Z
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2014
• 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