MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC EGIA ULTRA UNIVERSAL STAPLER; STAPLE, IMPLANTABLE

Model Number EGIAUSTND

Device Problem Failure to Disconnect (2541)

Patient Problem No Code Available (3191)

Event Date 12/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a ventricular assisted device (vad) procedure, the jaws would not open following firing of the device.The tissue had to be resected.The patient is currently doing fine.

Manufacturer Narrative

(b)(4).Evaluation summary: post market vigilance (pmv) concurrently with engineering led an evaluation of one device and one reload.The instrument was received engaged with the reload.The instrument firing knobs were fully advanced and the articulation lever was in neutral position.Visual examination of the reload noted that it was fully fired with the jaws clamped and the knife bar assembly advanced to the extreme distal end.The instrument firing knobs were retracted fully, allowing for release of reload jaws.The reload was unloaded without difficulty.Functionally, the instrument was loaded with an endo gia* universal roticulator* 60-3.5 single use loading unit.During the firing cycle, a skip was audible in the firing stroke.An access hole was cut into the instrument body for visualization of the firing rack.This examination noted sheared teeth on the firing rack.The reload was then loaded onto the a pmv instrument for functional testing.It was observed that the anvil could not be closed completely on the initial clamping stroke.This was an indication that the reload anvil was deformed at the clamping feature.The reload was cycled without hesitation or binding and the jaws opened after the instrument firing knobs were fully retracted.Functional testing confirmed the safety interlock feature successfully prevented the reload from cycling again.During this investigation, a secondary condition was identified as follows.There were sheared teeth on the instrument firing rack and the reload anvil clamping mechanism was deformed a review of the device history records indicates each device lot number was released meeting all quality release specifications at the time of manufacture.Replication of the sheared teeth on the firing rack and deformed anvil clamping mechanism may occur in any of the following circumstances: firing over tissue that is beyond the recommended thickness range.Firing with an obstacle incorporated in the jaws.In either of these circumstances, it will become increasingly difficult to actuate the firing handle and the instrument return knobs will be difficult to retract.In addition, staples may not form properly and tissue may not be fully transected.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• Brand Name: EGIA ULTRA UNIVERSAL STAPLER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6258310
• MDR Text Key: 65004964
• Report Number: 2647580-2017-00058
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: EGIAUSTND
• Device Catalogue Number: EGIAUSTND
• Device Lot Number: P6J0421X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: EGIA 60 ARTICULATING VAS/MED SULU
• Patient Outcome(s): Required Intervention