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

Device Problem Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 11/04/2015

Event Type  malfunction  

Event Description

Generator attached to the myosure handpiece stopped working at approximately two-thirds of completion of surgery.The case had to be aborted.

• Brand Name: MYOSURE
• Type of Device: HYSTEROSCOPE AND ACCESSORIES
• Manufacturer (Section D): HOLOGIC INC; 35 crosby drive; bedford MA 01730
• MDR Report Key: 5243204
• MDR Text Key: 31929367
• Report Number: 5243204
• 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: Attorney
• Type of Report: Initial
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/05/2015
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/05/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/23/2015
• 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
• Treatment: NO OTHER THERAPIES
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Weight: 83