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

Model Number 30-401LITE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 12/14/2017

Event Type  malfunction  

Event Description

The device did not function properly to remove polyp.

• Brand Name: MYOSURE TISSUE REMOVAL DEVICE
• Type of Device: HYSTEROSCOPE, ACCESSORIES
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlboro MA 01752
• MDR Report Key: 7171219
• MDR Text Key: 96611069
• Report Number: 7171219
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2017

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?: Yes
• Device Operator: No Information
• Device Model Number: 30-401LITE
• Device Catalogue Number: 30-401LITE
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR