FDA Adverse Event
Other
Summary report: N
FLEXIBLE SCOPE
MDR report key: 2094060
·
Received April 29, 2011
Report
- Report Number
- 1218764-2011-00002
- Event Type
- Other
- Date Received
- April 29, 2011
- Date of Event
- March 31, 2011
- Report Date
- April 29, 2011
- Manufacturer
- GYRUS ACMI, INC.
- Product Code
- FAJ
- PMA / PMN Number
- K042225
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS CURRENTLY STILL UNDER INVESTIGATION AND TESTING AT OUR FACILITY. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. WHEN FURTHER INFO BECOMES AVAILABLE, GYRUS (B)(4) WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.
Description of Event or Problem · 1
DURING A PCNL PROCEDURE WHILE USING THE FLEXIBLE SCOPE, THE SURGEON GOT SHOCKED IN PALM OF HAND. THERE WAS A LASER FIBER IN THE CHANNEL, BUT LASER WAS NOT ACTIVATED AT THE TIME. THE SURGEON HAD TWO PAIRS OF GLOVES ON, NO HOLES WERE NOTED IN THE GLOVES, NO EXTERNAL INJURIES ON HANDS. THE OTHER PRODUCTS USED IN THIS PROCEDURE WAS THE (B)(4), WHICH IS ALSO BEING REPORTED ON MFR REPORT #1218764-2011-00003.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLEXIBLE SCOPE | FLEXIBLE SCOPE | FAJ | GYRUS ACMI, INC. | REXICN-0564 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |