MAUDE Adverse Event Report: HOLOGIC INC MYOSURE NOVA; HYSTEROSCOPE (AND ACCESSORIES)

Device Problem Use of Device Problem (1670)

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

Event Date 01/24/2019

Event Type  No Answer Provided  

Event Description

Physician was performing a hysteroscopy, dilatation and curettage with hologic myosure.The staff set up the myosure canisters.The physician asked for larger scope and the staff realized that the 400 ml deficit was in the canisters.Two or more liters of fluid had been infused.The myosure was alarming and the staff was unable to reset the equipment.The physician had to switch to a hysteroscope.The procedure was delayed several minutes and the fibroid samples had gone in the canisters.Solidifier was in the canister and staff could not retrieve the samples.

• Brand Name: MYOSURE NOVA
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC INC
• MDR Report Key: 8362243
• MDR Text Key: 137122821
• Report Number: MW5084207
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/21/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 138