MAUDE Adverse Event Report: COVIDIEN ENDO GIA STAPLER; ENDO GIA STAPLER

Model Number EGIA USTND

Device Problems Failure to Fire (2610); Noise, Audible (3273)

Patient Problems Hemorrhage/Bleeding (1888); Atrial Perforation (2511)

Event Date 09/15/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, pt was admitted and underwent a right hand assisted laparoscopic nephrectomy.During procedure, the surgery was using a covidien stapler across the renal artery and heard a "loud crack and stapler did not fire." at that point, the surgeon noted that the renal artery was severed and was able to clamp artery and maintain control.The surgeon made the decision to convert to an open nephrectomy.Post op, pt was stable and discharged home on (b)(6) 2017.

• Brand Name: ENDO GIA STAPLER
• Type of Device: ENDO GIA STAPLER
• Manufacturer (Section D): COVIDIEN; garden groves MO 63119
• MDR Report Key: 6913946
• MDR Text Key: 88240022
• Report Number: MW5072579
• Device Sequence Number: 1
• Product Code: GAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/02/2017

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 Model Number: EGIA USTND
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Weight: 108