MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-18 for FLEX SHAFT II * manufactured by Power Medical Interventions.
[511671]
During procedure sales representative informed us that the flexible shaft ii sigmoid scope was not cleaned according to manufacturer's recommendations. Our standard procedure has been to flash autoclave for 3 minutes. Flash sterilization should not be done. Scope should be autoclaved for standard time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 761903 |
| MDR Report Key | 761903 |
| Date Received | 2006-08-18 |
| Date of Report | 2006-08-18 |
| Date of Event | 2006-06-01 |
| Report Date | 2006-08-18 |
| Date Reported to FDA | 2006-08-18 |
| Date Added to Maude | 2006-09-20 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEX SHAFT II |
| Generic Name | SIGMOID SCOPE |
| Product Code | FAM |
| Date Received | 2006-08-18 |
| Model Number | FLEX SHAFT II |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 749794 |
| Manufacturer | POWER MEDICAL INTERVENTIONS |
| Manufacturer Address | 2021 CABOT BOULEVARD WEST LANGHORNE PA 19047 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-18 |