MAUDE Adverse Event Report: HOLOGIC, INC. SURESOUND; UTERINE SOUNDING DEVICE

Model Number NS2013KIT

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.Internal complaint reference: (b)(4).

Event Description

It was reported that during a novasure endometrial ablation procedure the physician was having trouble measuring the cavity using the suresound device.When the physician removed the device they noticed that three of the prongs were missing.The physician completed the ablation and then scoped the patient and noticed the three progs in the patient's uterus.A dilation and curretage were performed, but the physician did not have graspers and only two of the prongs were able to be removed."the physician is bringing the patient back asap to have the other one removed which will be at their other facility.".

Event Description

Additional information obtained noted that the patient did return to have the remaining prong removed and the physician was able to do so with graspers.Physician follow-up with the patient noted no further issues.

Manufacturer Narrative

The returned device was received and it was confirmed that the prongs were broken.The exact root cause is unknown at this time.This issue has been escalated for review and (b)(4) has been initiated.

• Brand Name: SURESOUND
• Type of Device: UTERINE SOUNDING DEVICE
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 8506510
• MDR Text Key: 141725483
• Report Number: 1222780-2019-00083
• Device Sequence Number: 1
• Product Code: HHM
• UDI-Device Identifier: 45420045501127
• UDI-Public: 45420045501127
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2021
• Device Model Number: NS2013KIT
• Device Catalogue Number: NS2013KIT
• Device Lot Number: 18M03RC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Date Manufacturer Received: 05/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention