FDA Adverse Event
Injury
Summary report: N
PKS SUPERPLUS GENERATOR
MDR report key: 3111166
·
Received May 8, 2013
Report
- Report Number
- 9617070-2013-00010
- Event Type
- Injury
- Date Received
- May 8, 2013
- Report Date
- April 12, 2013
- Manufacturer
- GYRUS MEDICAL LTD.
- Product Code
- GEI
- PMA / PMN Number
- K031085
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED TO GYRUSACMI THAT AFTER A TURP PROCEDURE AT THE FOLLOW UP APPOINTMENT, THE PATIENT COMPLAINED OF BURNS ON PENIS. IT WAS NOT KNOWN HOW OR WHEN THE BURNS WERE RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 200140 | PKS SUPERPLUS GENERATOR | PKS SUPERPULSE GENERATOR | GEI | GYRUS MEDICAL LTD. | 744000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |