MAUDE Adverse Event Report: MEDTRONICS COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER 12MM; NONE

Model Number EGIAUSTND

Device Problems Crack (1135); Positioning Failure (1158); Difficult to Remove (1528)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 06/26/2017

Event Type  Injury  

Event Description

To operating room for emergency laparoscopic appendectomy: the lines of staples fired appropriately.The knife would not deploy to transect the tissue.The device clamped onto the appendix and would not release.The handle cracked when attempting to deploy the knife.

• Brand Name: COVIDIEN ENDO GIA ULTRA UNIVERSAL STAPLER 12MM
• Type of Device: NONE
• Manufacturer (Section D): MEDTRONICS ; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 6689661
• MDR Text Key: 79279149
• Report Number: 6689661
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: EGIAUSTND
• Device Lot Number: P7A1450X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/27/2017
• Event Location: Hospital
• 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: 55 YR
• Patient Weight: 86