MAUDE Adverse Event Report: COVIDIEN COVIDIEN TRUCLEAR; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 72204878

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 09/20/2021

Event Type  malfunction  

Event Description

Covidien truclear scope has hair line fracture.Left 1" burn on patient.Fda safety report id # (b)(4).

• Brand Name: COVIDIEN TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 12532528
• MDR Text Key: 273676271
• Report Number: MW5104200
• Device Sequence Number: 1
• Product Code: HIH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 72204878
• Device Catalogue Number: 72204878
• Device Lot Number: (21)1493294
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2021
• 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): Other