FDA Adverse Event
Malfunction
Summary report: N
PENTAX
MDR report key: 5205300
·
Received November 5, 2015
Report
- Report Number
- 9610877-2015-00029
- Event Type
- Malfunction
- Date Received
- November 5, 2015
- Report Date
- October 9, 2015
- Manufacturer
- HOYA CORPORATION PENTAX TOKYO OFFICE
- Product Code
- FDT
- PMA / PMN Number
- K092710
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2015, PENTAX MEDICAL RECEIVED A CUSTOMER REPORT STATING VIDEO DUODENOSCOPE MODEL ED-3490TK/(B)(4) TESTED POSITIVE FOR CARBOHYDRATES, PROTEIN, AND BLOOD VIA THE HEALTH MARK INDUSTRIES CHANNEL CHECK PROCESS. THE DATE OF TESTING WAS (B)(6) 2015. PREVIOUS COMMUNICATION WITH THE FACILITY CONFIRMED THAT EVERY DUODENOSCOPE IS TESTED FOR CARBOHYDRATES, PROTEIN, AND BLOOD PRIOR TO BEING USED IN A PATIENT CARE SETTING (REFER TO MDR# 2518897-2015-00025), AS A RISK MITIGATION STEP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 736973 | PENTAX | VIDEO DUODENOSCOPE | FDT | HOYA CORPORATION PENTAX TOKYO OFFICE | ED-3490TK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |