MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-11 for SURESOUND NS2013KIT manufactured by Hologic, Inc..
[141725483]
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).
Patient Sequence No: 1, Text Type: N, H10
[141725484]
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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222780-2019-00083 |
| MDR Report Key | 8506510 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-11 |
| Date of Report | 2019-03-21 |
| Date of Event | 2019-03-21 |
| Date Mfgr Received | 2019-05-09 |
| Device Manufacturer Date | 2018-12-03 |
| Date Added to Maude | 2019-04-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KRISTIN FORNIERI |
| Manufacturer Street | 36 & 37 APPLE RIDGE ROAD |
| Manufacturer City | DANBURY CT 06810 |
| Manufacturer Country | US |
| Manufacturer Postal | 06810 |
| Manufacturer Phone | 2037318491 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURESOUND |
| Generic Name | UTERINE SOUNDING DEVICE |
| Product Code | HHM |
| Date Received | 2019-04-11 |
| Returned To Mfg | 2019-04-15 |
| Model Number | NS2013KIT |
| Catalog Number | NS2013KIT |
| Lot Number | 18M03RC |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-04-11 |