FDA Adverse Event
Injury
Summary report: N
MYOSURE TISSUE REMOVAL DEVICE
MDR report key: 1910295
·
Received November 23, 2010
Report
- Report Number
- 3006659293-2010-00003
- Event Type
- Injury
- Date Received
- November 23, 2010
- Date of Event
- October 25, 2010
- Report Date
- November 23, 2010
- Manufacturer
- INTERLACE MEDICAL, INC.
- Product Code
- HIH
- PMA / PMN Number
- K091100
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING A MYOSURE PROCEDURE TO REMOVE A 3.8CM MYOMA, THE DEVICE WAS BEING REPOSITIONED INSIDE THE UTERUS AND INADVERTENTLY PUSHED THROUGH FUNDUS. DEVICE WAS NOT CUTTING AT THE TIME OF PERFORATION. DOCTOR IMMEDIATELY REMOVED THE MYOSURE DEVICE, AND A LAPAROSCOPY WAS PERFORMED TO ASSESS THE EXTENT OF THE PERFORATION. A SMALL BLUNT TRAUMA TO THE BOWEL WAS IDENTIFIED AND SUTURED. PATIENT WAS HOSPITALIZED FOR EVALUATION AND SUBSEQUENTLY RELEASED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MYOSURE TISSUE REMOVAL DEVICE | HYSTEROSCOPE AND ACCESSORIES | HIH | INTERLACE MEDICAL, INC. | 10-401 | 100823-029 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |