FDA Adverse Event
Injury
Summary report: N
FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE
MDR report key: 856164
·
Received May 25, 2007
Report
- Report Number
- 3004014191-2007-00001
- Event Type
- Injury
- Date Received
- May 25, 2007
- Date of Event
- April 30, 2007
- Report Date
- April 30, 2007
- Manufacturer
- RUBICOR MEDICAL, INC.
- Product Code
- GEI
- PMA / PMN Number
- K070275
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PATIENT IS A FEMALE WITH INVASIVE DUCTAL CARCINOMA. DURING INSERTION OF THE FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE IN 2007, AT 9:30AM, THE PHYSICIAN UNKNOWINGLY ENTERED THE PATIENT'S CHEST CAVITY WITH THE TIP OF THE DEVICE. USE OF THE DEVICE TO CUT SOFT TISSUE CONTINUED AS PLANNED. PRIOR TO CLOSURE, THE PHYSICIAN NOTED THE INJURY. THE PHYSICIAN CALLED THE CARDIOVASCULAR SURGEON FOR CONSULT. THE CARDIOVASCULAR SURGEON RECOMMENDED PLACING A LATERAL STITCH IN THE 1-CM INCISION. THE CARDIOVASCULAR SURGEON THEN PROCEEDED TO INSERT A DRAINAGE TUBE AND PLACED THE STITCH. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE NEXT MONTH. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION. THE DEVICE WAS DISPOSED OF AT THE CUSTOMER SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXIBLE LOOP ELECTROSURGICAL ELECTRODE | ELECTROSURGICAL ELECTRODE | GEI | RUBICOR MEDICAL, INC. | 7000 | 07031702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R |