FDA Adverse Event
Injury
Summary report: N
HER OPTION PROBE
MDR report key: 2088029
·
Received May 6, 2011
Report
- Report Number
- 1216677-2011-00006
- Event Type
- Injury
- Date Received
- May 6, 2011
- Date of Event
- April 21, 2011
- Report Date
- May 4, 2011
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- GEH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
HER OPTION PROBE HAS NOT BEEN RETURNED TO COOPERSURGICAL INC FOR EVALUATION. (B)(4).
Description of Event or Problem · 1
THE PATIENT SUFFERED A UTERINE PERFORATION WHILE UNDERGOING CRYO-ABLATION WITH A HER OPTION PROBE. THE PATIENT HAD TO UNDERGO A PARTIAL SMALL BOWEL RESECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HER OPTION PROBE | NONE | GEH | COOPERSURGICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |