MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-12 for NON DISPOSABLE UNK manufactured by Olympus America.
[16279358]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1013958 |
| MDR Report Key | 172343 |
| Date Received | 1998-06-12 |
| Date of Report | 1998-06-12 |
| Date Added to Maude | 1998-06-16 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NON DISPOSABLE |
| Generic Name | FLEXIBLE SIGMOIDOSCOPY |
| Product Code | FAM |
| Date Received | 1998-06-12 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 167583 |
| Manufacturer | OLYMPUS AMERICA |
| Manufacturer Address | TWO CORPORATE CENTER DR. MELVILLE NY 117473157 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-06-12 |