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

Catalog Number 7209807

Device Problem Contamination (1120)

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

Event Date 01/21/2022

Event Type  malfunction  

Event Description

Truclear shavers were discovered to have a green substance stuck to the internal lumen of the shaver.Sales rep and medtronic quality department advised that this is the bonding agent seeping out from where the spigot attaches to the hand piece housing, and that it is "normal" and does not warrant a repair.Fda safety report id# (b)(4).

Event Description

Truclear shavers were discovered to have a green substance stuck to the internal lumen of the shaver.Sales rep and medtronic quality department advised that this is the bonding agent seeping out from where the spigot attaches to the hand piece housing, and that it is "normal" and does not warrant a repair.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MEDTRONIC / COVIDIEN; new haven CT 06511
• MDR Report Key: 13425769
• MDR Text Key: 285179190
• Report Number: MW5107149
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7209807
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1