FDA Adverse Event
Other
Summary report: N
MR-6LA
MDR report key: 972160
·
Received December 19, 2007
Report
- Report Number
- 1519132-2007-00010
- Event Type
- Other
- Date Received
- December 19, 2007
- Date of Event
- November 27, 2007
- Report Date
- December 19, 2007
- Manufacturer
- GYRUS ACMI, INC. - NORWALK
- Product Code
- FGB
- PMA / PMN Number
- K052044
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AT THE TIME OF THIS REPORT, MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFO FROM THE HOSP HAVE BEEN UNSUCCESSFUL, AND THE DEVICE HAS NOT YET BEEN RETURNED FOR EVAL. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. WHEN FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.
Description of Event or Problem · 1
DURING A PROCEDURE USING THE URETEROSCOPE, THE URETER WAS PERFORATED. TIP IS TOO SHARP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MR-6LA | URETEROSCOPE, 43 CM | FGB | GYRUS ACMI, INC. - NORWALK | MR-6LA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR |