MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-14 for USA ELITE SYSTEM ROTATING CF OUTER SHEATH, 25 FR, GOLD EROS-CF25 manufactured by Gyrus Acmi, Inc.
[93194895]
The device was not returned to olympus for evaluation. Olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result. The exact cause of the reported event cannot be determined at this time. However, the instruction manual warns users "do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged. Damage may result in the loss of the entire ceramic tip or fragments of the ceramic tip. If there is evidence of charring, burn spots, chips or cracks in the ceramic tip or surrounding area, do not use. "
Patient Sequence No: 1, Text Type: N, H10
[93194896]
Olympus was informed that during an unspecified procedure, the plastic tip of the outer sheath broke off into three pieces and fell inside the patient. It was reported that the surgeon retrieved all three pieces of the plastic tip from the patient. The adjacent areas were inspected for trauma and none was noted. It is unknown if the intended procedure was completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00723 |
| MDR Report Key | 7031775 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-14 |
| Date of Report | 2017-11-14 |
| Date of Event | 2017-09-18 |
| Date Mfgr Received | 2017-10-27 |
| Date Added to Maude | 2017-11-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | USA ELITE SYSTEM ROTATING CF OUTER SHEATH, 25 FR, GOLD |
| Generic Name | USA ELITE SYSTEM ROTATING CF OUTER SHEATH |
| Product Code | FBO |
| Date Received | 2017-11-14 |
| Model Number | EROS-CF25 |
| Catalog Number | EROS-CF25 |
| Lot Number | UNKNOWN |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-14 |