MAUDE Adverse Event Report: HOLOGIC INC. MYOSURE LIFE SUCTION TUBING; HYSTEROSCOPE (AND ACCESSORIES)

Lot Number 18L20RA

Device Problem Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2019

Event Type  malfunction  

Event Description

During surgical procedure the myosure suction tubing had intermittent suction resulting in tube movement.Tubing was exchanged and suction worked properly.Fda safety report id# (b)(4).

• Brand Name: MYOSURE LIFE SUCTION TUBING
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC INC.
• MDR Report Key: 8599701
• MDR Text Key: 144837123
• Report Number: MW5086520
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 18L20RA
• Was Device Available for Evaluation?: No
• 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