MAUDE Adverse Event Report: COVIDIEN COVIDIEN HEMORRHOID AND PROLAPSE STAPLER; STAPLE, IMPLANTABLE

Model Number HEM3335

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2021

Event Type  malfunction  

Event Description

Covidien hemorrhoid and prolapse stapler 33mm-3.5mm, ref hem3335, lot#n9j0065my malfunctioned.It cracked before firing.No injury made on patient.Fda safety report id# (b)(4).

• Brand Name: COVIDIEN HEMORRHOID AND PROLAPSE STAPLER
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN ; mansfield MA 02048
• MDR Report Key: 12040464
• MDR Text Key: 257749460
• Report Number: MW5102003
• Device Sequence Number: 1
• Product Code: GDW
• 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: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HEM3335
• Device Catalogue Number: HEM3335
• Device Lot Number: N9J0065MY
• Was Device Available for Evaluation?: Yes
• 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 Age: 33 YR
• Patient Weight: 80