MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ECHELON LINEAR CUTTER; STAPLE, IMPLANTABLE

Catalog Number PLE60A

Device Problem Torn Material (3024)

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

Event Date 10/01/2014

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic gastric sleeve procedure, the surgeon fired across the stomach with green reloads for the first two firings, when the tech reloaded the device for the third firing with a gold reload it was noticed that the black joint cover was torn.They used a second like device and completed the procedure.There was no patient consequence reported.

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.At the time of this submission, the device has not been returned for analysis.

Manufacturer Narrative

(b)(4).Additional information: the analysis found that one ple60a device was returned in good visual condition and with no cartridge loaded on the device.The device was tested for functionality in the straight position with a test cartridge reload and achieved its complete firing sequence without any difficulties.The staple line and cut line were complete and the staples were noted to have the proper b-form shape.Upon further inspection the joint cover was noted to be torn; there is no evidence that there is any portion of the joint cover missing.It is possible that the device was attempted to be pulled out from a trocar in the articulated position, resulting in the edge of the trocar damaging the joint cover.It should be noted that a 100% inspections takes place during manufacturing to ensure the device meets the required specifications.The batch record was reviewed and no anomalies were noted during the manufacturing process.

• Brand Name: ECHELON LINEAR CUTTER
• Type of Device: STAPLE, 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: 4206517
• MDR Text Key: 5151108
• Report Number: 3005075853-2014-07434
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110385
• 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,Followup
• Report Date: 10/09/2014

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: PLE60A
• Device Lot Number: L4F06N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 10/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2014
• 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
• Treatment: RELOAD: ECR60D,ECR60G