NON DISPOSABLE
Received Jun 12, 1998
Report MW1013958 · MDR key 172343
Device
Generic name
Flexible Sigmoidoscopy
Manufacturer
Olympus AmericaModel number
UNKCatalog number
UNK
Lot number
UNK
Product problems
- Device Reprocessing Problem
- Contamination
- Use of Device Problem
Patient
UNKNOWN
- Hepatitis
- Unspecified Infection
- HIV, Human Immunodeficiency Virus
Narrative
Description of Event or Problem
ARE ABOUT 2.5 MILLIN EXAMS DONE A YR WITH THIS DEVICE. ONLY ABOUT 25,000 DISPOSABLE UNITS ARE SOLD. MAJORITY OF PTS ARE 50 YRS OLD OR OLDER. THE COST OF DISPOSABLE ARE MUCH GREATER THAN THE NON DISPOSABLE AND FACILITIES ARE CONTINUING TO USE THE NON DISPOSABLE FOR ECONOMIC REASONS. PROBLEM IS THE DEVICE IS NOT BEING AUTOCLAVED OR OTHERWISE STERILIZED PROPERLY AND DISEASES SUCH AS HIV, HEPATITIS, AND SEXUALLY TRANSMITTED DISEASES ARE BEING CONTRACTED FROM THIS DEVICE. THIS PROBLEM IS HARD TO TRACK DUE TO THE LARGE TIME LAPSE BETWEEN THE USE OF THE DEVICE AND THE SYMPTOMS APPEARING. BECAUSE OF THE SMALL PROPERTIES AND COMPLEXITY OF THE DEVICE IT IS DIFFICULT TO CLEAN AND IT IS BELIEVED THE DEVICES ARE NOT BEING CLEANED PROPERLY: IMPROPER TRAINING, SCHEDULED PROCEDURES BACK TO BACK NOT ALLOWING FOR PROPER CLEANING TIME FOR DEVICE TO BE SOAKED IN CLEANING SOLUTION.