MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-11 for WELCH ALLYN 73305 38119 manufactured by Welch Allyn.
[16580161]
Welch allyn: the sterilization processes for various pieces of the sigmoidoscope / anoscope. My 3 main concerns on welch allyn's ifu's were sterilizing some of the parts on a gravity cycle for 6 minutes at 270, sterilization validation on a sterrad nx (rather than just the sterrad 100s) making the cleaning agent less product specific (caviwipes) and recommend only cleaning agents or classes of agents. I spoke to a gentleman on the phone about these issues, and he had said he would look into some of these things. He had emailed me the fda rules for manufacturers and tried explaining that they have to follow strict processes. I cut and pasted the following, pointing out that welch allyn isn't necessarily following the fda guidelines. "criterion 6: the instructions should be comprehensive. " cleaning agents the instructions should recommend only cleaning agents or classes of agents (e. G. , anionic detergents, surface-active detergent/disinfectants such as quarternary ammonium compounds, and enzymatic detergents) that were used during the cleaning validation studies and that have been demonstrated to be compatible with the device and are effective cleaning agents. Item exposure time at 132 degrees c -270 degrees f, wrapped instruments 30 minutes, ansi/aami st79:2010 and a1:2010 comprehensive guide to steam sterilization and sterility assurance in health care facilities. Published by the association for the advancement of medical instrumentation (aami). C. 2010 aami www. Aami. Org. Some of the instruments in this set have to be sent to another facility to be processed in a sterrad 100s. Some parts need to be disinfected with caviwipes (which we will have to special order), other pieces have to be processed in cidex opa, and other parts are to be sterilized on gravity 270 for 6 minutes. This isn't even a valid cycle. Thank you for your time looking into this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026904 |
| MDR Report Key | 2747021 |
| Date Received | 2012-09-11 |
| Date of Report | 2012-09-11 |
| Date Added to Maude | 2012-09-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WELCH ALLYN |
| Generic Name | RIGID REUSABLE SIGMOIDOSCOPE |
| Product Code | GCF |
| Date Received | 2012-09-11 |
| Model Number | 73305 |
| Catalog Number | 38119 |
| Operator | OTHER |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | 4341 STATE STREET RD. SKANEATELES FALLS NY 13153 US 13153 |
| Brand Name | WELCH ALLYN |
| Generic Name | ANOSCOPE |
| Product Code | FER |
| Date Received | 2012-09-11 |
| Model Number | 53130 |
| Catalog Number | 36019 |
| Operator | OTHER |
| Device Availability | N |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | 4341 STATE STREET RD. SKANEATELES FALLS NY 13153 US 13153 |
| Brand Name | WELCH ALLYN |
| Generic Name | ACCESSORIES |
| Product Code | FER |
| Date Received | 2012-09-11 |
| Model Number | 30210 |
| Catalog Number | 38700 |
| Operator | OTHER |
| Device Availability | N |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | 4341 STATE STREET RD. SKANEATELES FALLS NY 13153 US 13153 |
| Brand Name | WELCH ALLYN |
| Generic Name | ACCESSORIES |
| Product Code | FER |
| Date Received | 2012-09-11 |
| Catalog Number | 7 |
| Operator | OTHER |
| Device Availability | N |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | 4341 STATE STREET RD. SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-11 |