FDA Adverse Event
Malfunction
Summary report: N
PENTAX MEDICAL COMPANY
MDR report key: 1598497
·
Received February 2, 2010
Report
- Report Number
- MW5014644
- Event Type
- Malfunction
- Date Received
- February 2, 2010
- Report Date
- February 2, 2010
- Manufacturer
- PENTAX MEDICAL COMPANY
- Product Code
- EOQ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THROUGH INTERNAL QUALITY ASSURANCE TESTING, WE IDENTIFIED A PROBLEM THAT WAS TRACED BACK TO A SPECIFIC BRONCHOSCOPE MANUFACTURED BY PENTAX. EVALUATION OF THE BRONCHOSCOPE REVEALED THAT THE "SUCTION NIPPLE" ON THE SCOPE WAS LOOSE. IT WOULD ROTATE, WITH FINGER PRESSURE ONLY, APPROXIMATELY 30 TO 45 DEGREES AND WOULD EASILY WIGGLE WHEN IN THE CENTER OF ROTATION. FURTHER INVESTIGATION FOUND THE EXACT SAME PROBLEM IN THREE OF OUR 5 PENTAX BRONCHOSCOPES, AS WELL AS A LOANER BRONCHOSCOPE WHICH WE HAD WHILE OUR FIFTH SCOPE WAS OUT FOR REPAIR. WE BROADENED OUR SEARCH TO DIFFERENT DEPARTMENTS AND HAVE DISCOVERED THE SAME PROBLEM IN AT LEAST THREE OTHER PENTAX SCOPE MODELS THAT SHARE THE SAME CONTROL BODY DESIGN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PENTAX MEDICAL COMPANY | VIDEO BRONCHOSCOPE | EOQ | PENTAX MEDICAL COMPANY | EB-1570K | ||
| 2 | PENTAX MEDICAL COMPANY | VIDEO RHINOLARYNGOSCOPE | GCI | PENTAX MEDICAL COMPANY | VNL-1170K |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |