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

Model Number 30-401LITE

Device Problem Defective Device (2588)

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

Event Date 06/07/2019

Event Type  malfunction  

Event Description

Device would not continue to work without foot pedal pressed.

• Brand Name: MYOSURE TISSUE REMOVAL DEVICE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus dr; marlburough MA 01752
• MDR Report Key: 9171952
• MDR Text Key: 161722663
• Report Number: 9171952
• 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: 09/26/2019,09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 30-401LITE
• Device Catalogue Number: 30-401LITE
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1