MAUDE Adverse Event Report: COVIDIEN CIRCULAR STAPLER WITH TRI STAPLE; STAPLER, SURGICAL

Model Number TRIEEA31MT

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Blood Loss (2597)

Event Date 07/29/2020

Event Type  Injury  

Event Description

Open laparotomy procedure.Cytoreduction with sigmoid/recital resection.Using a circular stapler, the staples did not deploy.Forced to hand sew the anastomosis, extended the procedure by 60 minutes.No significant increase in blood loss.Pt is recovering.No apparent sequelae from eea failure.Fda safety report id# (b)(4).

• Brand Name: CIRCULAR STAPLER WITH TRI STAPLE
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10367070
• MDR Text Key: 201855368
• Report Number: MW5095880
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: TRIEEA31MT
• Device Lot Number: P8M1181Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Is the Reporter a Health Professional?: Yes
• 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: 64 YR