MAUDE Adverse Event Report: HOLOGIC, INC. MYOSURE HYSTEROSCOPY; HYSTEROSCOPE (AND ACCESSORIES)

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 11/07/2018

Event Type  malfunction  

Event Description

Surgeon was using myosure hysteroscopy equipment and it did not work during case.

• Brand Name: MYOSURE HYSTEROSCOPY
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlboro MA 01752
• MDR Report Key: 9128807
• MDR Text Key: 160364955
• Report Number: 9128807
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11315 DA