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

Model Number NS2013

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Uterine Perforation (2121)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

Lot and serial number of the disposable device not provided by the complainant, therefore the expiration date is not known.The device is not being returned therefore, a failure analysis of the complaint device cannot be completed.If additional relevant information is received or device evaluation completed, a supplemental medwatch will be filed.Lot number of the disposable device not provided by the complainant, therefore the manufacture date is not known.Device history record (dhr) review was unable to be conducted for the disposable device as the identification numbers were not provided.

Event Description

It was reported that during uterine sounding, the uterus was perforated.It was noted that there was no resistance felt during sounding.Because of the perforation, the ablation was not completed.No additional details available.

Manufacturer Narrative

The returned device was received and the investigator did not find anything wrong with the suresound.There were no visual imperfections found with the device during laboratory testing.The product passed functional testing.This is being trended and monitored.

• Brand Name: SURESOUND
• Type of Device: UTERINE SOUNDING DEVICE,
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• MDR Report Key: 9358510
• MDR Text Key: 167605312
• Report Number: 1222780-2019-00264
• Device Sequence Number: 1
• Product Code: HHM
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NS2013
• Device Catalogue Number: NS2013
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Date Manufacturer Received: 10/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other