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

Model Number 10-401

Device Problems Bent (1059); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 03/15/2017

Event Type  malfunction  

Event Description

While using the myosure, the surgeon heard a loud pop.Upon examination, the tip of the myosure that sticks out of the myosure scope was visibly bent.Manufacturer response for tissue removal system, hologic myosure (per site reporter): manufacturer provided rga# and shipping container for product return.

• Brand Name: MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 6515344
• MDR Text Key: 73477494
• Report Number: 6515344
• 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: 04/11/2017

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: Physician
• Device Expiration Date: 06/01/2019
• Device Model Number: 10-401
• Device Catalogue Number: 10-401
• Device Lot Number: 16G14RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 147