FDA Adverse Event
Malfunction
Summary report: N
PENTAX
MDR report key: 2338644
·
Received November 10, 2011
Report
- Report Number
- 2518897-2011-00005
- Event Type
- Malfunction
- Date Received
- November 10, 2011
- Date of Event
- October 13, 2011
- Report Date
- November 10, 2011
- Manufacturer
- PENTAX MEDICAL COMPANY
- Product Code
- KOG
- PMA / PMN Number
- K934918
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- MD, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE EPK-1000 PASSED FUNCTIONAL TESTING. THE INVESTIGATION IS ONGOING.
Description of Event or Problem · 1
THE NURSE ON SITE REPORTED: WHEN USING THE EPK-1000 VIDEO PROCESSOR WITH THE PENTAX SCOPES THERE IS A BLACKOUT ON THE MONITOR WHEN CAUTERIZING WITH THE ERBE MACHINE. THIS COULD BE VERY DANGEROUS TO OUR PTS. WE HAVE CHANGED OUT THE ERBE MACHINE WITH ANOTHER ONE FROM ANOTHER ROOM AND THE RESULTS ARE THE SAME - BLACKOUT ON SCOPE WHILE CAUTERIZING. WE HAVE NOT HAD ANY PT INJURIES TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENTAX | VIDEO PROCESSOR | KOG | PENTAX MEDICAL COMPANY | EPK-1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | ERBE ICC E INT U: SN# (B)(4), TYPE# 10128-204| ERBE ICC INT UL: SN# (B)(4), TYPE# 10128-202 |