MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON EGIA 30 CURVED TIP ARTICULATING VAS SULU; STAPLE, IMPLANTABLE

Model Number EGIA30CTAV

Device Problem Unintended Arm Motion (1033)

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

Event Date 10/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device has not been received.A supplemental report will be sent if device is received.

Event Description

According to the reporter, during an esophagectomy, when the surgeon approached the vein, the reload suddenly started to articulate by itself.The surgeon pressed the buttons in order to return the reload to the center position.However, the reload did not turn back.The surgeon drew the reload and released the tissue.Then the articulating button was pressed.The reload returned to the center position and was removed from the handle.A new set of devices was opened to continue the stapling.The original reload pre-fired.The event occurred in use for patient.The procedure was completed with another device.The surgical time was not extended.The status of the patient: no problem.Additional tissue resection is not required.There was no tissue damage.The incision site was not extended.Nothing fell into the patient's cavity.The device was removed from the tissue by force but no tissue damage was caused.No bleeding occurred.

Manufacturer Narrative

(b)(4).Handle and adapter not received.Evaluation summary: post market vigilance (pmv) led an evaluation of one reload opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends and an evaluation of the returned device.Visual inspection of the reload noted that it was pre-fired.Functional evaluation noted that the reload fired satisfactorily.Replication of the partial fire condition with interlock engagement may occur if the firing button had been pressed and then the open button was pressed after pressing the green firing button.In this situation, the safety interlock feature will engage and prevent the loading unit from firing a second time.Based on the product analysis, the failure was confirmed to be attributed to the reported event.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Brand Name: EGIA 30 CURVED TIP ARTICULATING VAS SULU
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6128518
• MDR Text Key: 60916313
• Report Number: 1219930-2016-01235
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EGIA30CTAV
• Device Catalogue Number: EGIA30CTAV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: HANDLE ((B)(6) 2016), ADAPTER ((B)(6) 2016)