MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-08-21 for SURESOUND SOUND12 manufactured by Hologic.
[3645426]
Note: this report pertains to the first of two hologic devices used in the same procedure. See associated medwatch 1222780-2013-00142. Prior to a novasure endometrial ablation on (b)(6) 2013, a hysteroscopy was performed and the physician noted "the fundus appeared fluffy and it is confirmed this involved [an] anteverted uterus". The disposable device was placed and then there were several unsuccessful cavity integrity assessment (cia) tests. The physician performed another hysteroscopy and found a perforation at or near the midline of the fundus. On (b)(6) 2013, it was reported that there was no intervention required. The pt was "fine [and] discharged uneventfully". A hysteroscopy and dilatation (non hologic devices) were performed prior to the attempted ablation. It is not known when this perforation occurred or what instrument may have been the cause.
Patient Sequence No: 1, Text Type: D, B5
[10922922]
Lot number of the suresound not provided by the complainant, therefore, the exp date is not known. The suresound is not being returned therefore, a failure analysis of the complaint device can not be completed. Lot number of the suresound not provided by complainant, therefore the mfr date is not known. Device history record (dhr) review could not be conducted for the suresound as a lot number was not provided by the complainant. According to the instructions for use (ifu) adverse events: potential adverse events include, but are not limited to perforation of the uterine wall. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222780-2013-00150 |
| MDR Report Key | 3313303 |
| Report Source | 05,06,07 |
| Date Received | 2013-08-21 |
| Date of Report | 2013-07-22 |
| Date of Event | 2013-07-22 |
| Date Facility Aware | 2013-07-22 |
| Date Mfgr Received | 2013-07-22 |
| Date Added to Maude | 2013-08-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CRAIG CALLAHAN, MGR |
| Manufacturer Street | 250 CAMPUS DRIVE |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5082638859 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURESOUND |
| Product Code | HHM |
| Date Received | 2013-08-21 |
| Model Number | NA |
| Catalog Number | SOUND12 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC |
| Manufacturer Address | MARLBOROUGH MA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-08-21 |