MAUDE Adverse Event Report: COVIDIEN EEA CIRCULAR STAPLER; STAPLER, SURGICAL

Lot Number P9J1064KY

Device Problems Misfire (2532); Failure to Form Staple (2579)

Patient Problem Insufficient Information (4580)

Event Date 09/23/2020

Event Type  malfunction  

Event Description

An eea circular stapler was misfired.An anastomotic donuts was created, but the stapler failed to form staples.A permanent ostomy was eventually created.Fda safety report id# (b)(4).

• Brand Name: EEA CIRCULAR STAPLER
• Type of Device: STAPLER, SURGICAL
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 10634350
• MDR Text Key: 210207254
• Report Number: MW5097079
• Device Sequence Number: 1
• Product Code: GAG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: P9J1064KY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Weight: 99