MAUDE Adverse Event Report: HOLOGIC INC. NOVASURE SURESOUND; SOUND, UTERINE

Catalog Number NS2007US

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Perforation (2001)

Event Date 01/29/2015

Event Type  Injury  

Event Description

The patient presented for diagnostic laparoscopy and uterine ablation.When the uterine ablation was completed, a laparoscopic view was taken, which showed two (2) areas of dermal penetration into the cornua of the uterus with perforation at the cornua; these were hemostatic.However, there were two areas of thermal spread on the right aspect of the rectum involving the peritoneum, approximately 2 cm in diameter.A sigmoidoscopy was performed by the general surgeon and both areas of the cautery injury were over-sewn."all areas of concern had been imbricated".Patient was transferred to post-anesthesia care unit (pacu) and discharged home in stable condition on the same day.

• Brand Name: NOVASURE SURESOUND
• Type of Device: SOUND, UTERINE
• Manufacturer (Section D): HOLOGIC INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 4696942
• MDR Text Key: 5639367
• Report Number: 4696942
• Device Sequence Number: 1
• Product Code: HHM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: NS2007US
• Device Lot Number: 14J08RC
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2015
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 86