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

Catalog Number LONG60A

Device Problems Difficult to Open or Close (2921); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Batch # p56h9t.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.The batch history records were reviewed and the manufacturing criteria were met prior to the release of this batch.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.What was the surgical procedure being performed?.Were all 4 strokes performed prior to attempting to open device?.Did surgeon use all troubleshooting steps before attempting to use unlock button?.Please describe torn tissue and what was done to address the torn tissue.What is the current patient status?.

Event Description

It was reported that during an unknown procedure, the first handle was closed without problem, then the physician closed the 2nd gray handle.The device did not open and when trying to open it, they noticed that the staples were still present.Impossible to release the 2 handles even when using the unlock button.The physician has closed back the 2 handles: the staples were delivered but the 1st handle was still not possible to release.The device was then removed in closed position.When the device was removed, the medical team saw the blade was not totally out and the tissues were torn.There were no other patient consequence reported.

Manufacturer Narrative

(b)(4).Batch # p56h9t.Device evaluation: the analysis found that one long60a device was returned with no apparent damage and with one ecr60d cartridge loaded in the device.The cartridge reload was received fully fired.The device was tested for functionality in the articulated 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.It should be noted that in order to open a device that has been partially fired or fully fired a reverse stroke needs to be performed trigger to trigger to handle in order to return the knife to the home position (indicator in the "0" position) and press the anvil release button to open.Event could not be confirmed as the device closed and opened without any difficulties noted.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.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: ECHELON ENDOPATH
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 6893891
• MDR Text Key: 89426286
• Report Number: 3005075853-2017-05185
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• PMA/PMN Number: K081146
• 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: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/05/2020
• Device Catalogue Number: LONG60A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2017
• 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