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 2012-11-08 for SURESOUND SOUND12 manufactured by Hologic.
[20636037]
Note: this report pertains to the first of two hologic devices used in the same procedure. See associated medwatch, manufacturer's report # 1222780-2012-00242. Following 2 unsuccessful cavity integrity assessment (cia) tests, on an "abnormally shaped uterus" during a novasure endometrial ablation, the physician did a hysteroscopy and saw a uterine perforation. Visualization was poor and the physician could not determine the location of the perforation. The patient consented to having a laparoscopic assisted vaginal hysterectomy (lavh) if the ablation could not be completed and was performed. A hysteroscopy, dilatation, and sounding with a metal sound (not hologic devices) were performed prior to the attempted ablation. It is now known when this perforation occurred or what instrument may have been the cause.
Patient Sequence No: 1, Text Type: D, B5
[20909869]
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 the complainant, therefore the manufacture 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 | 1222780-2012-00243 |
| MDR Report Key | 2836080 |
| Report Source | 05,06,07 |
| Date Received | 2012-11-08 |
| Date of Report | 2012-10-09 |
| Date of Event | 2012-10-09 |
| Date Facility Aware | 2012-10-09 |
| Date Mfgr Received | 2012-10-09 |
| Date Added to Maude | 2012-11-19 |
| 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, MANAGER |
| 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 | 2012-11-08 |
| 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. Hospitalization; 2. Required No Informationntervention | 2012-11-08 |