D
Patient 1
DURING A TRANSURETHRAL RESECTION OF THE PROSTATE PROCEDURE THEY EXPERIENCED ARCHING WITH THIS ELECTRODE. NO PT INJURY AND NO PARTS WERE LEFT BEHIND IN THE PT.
MAUDE MDR 2804100
- MDR report key
- 2804100
- Report number
- 3006159227-2012-00011
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-10-03
- Date received
- 2012-10-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- TERRENCE SULLIVAN
- Address
- 136 TURNPIKE RD. SOUTHBOROUGH MA 01772 US
- Phone
- 508-508-5088
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CUTTING LOOP | CUTTING LOOP | GYRUS ACMI, INC. | CBN | MLE-26-012 | MLE-26-012 | 361427 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-10-22 | 0 |
Event Narratives#
N
Patient 1
AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFO BECOMES AVAILABLE, GYRUS AMCI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.