MAUDE Adverse Event Report: COVIDIEN COVIDIEN ENDO GIA STAPLERS; STAPLER, SURGICAL

Model Number E GIA AU XL

Device Problem Mechanical Problem (1384)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/02/2018

Event Type  Injury  

Event Description

Endo stapler malfunctioned, caused bleeding.Add'l seam guards used to seal tissue.Report of add'l bleeding during a bariatric procedure.Reported to leadership, pulled product temporarily, using another brand.

• Brand Name: COVIDIEN ENDO GIA STAPLERS
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 7979014
• MDR Text Key: 124385345
• Report Number: MW5080650
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E GIA AU XL
• Is the Reporter a Health Professional?: No
• 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): Hospitalization
• Patient Age: 44 YR
• Patient Weight: 96