MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-05 for SHARPLAN ULTRASONIC ASPIRATOR TIP * AA-264-6700 manufactured by Fibra Sonics, Inc..
[17898357]
It has been reported that a neurosurgery department has encountered two instances of tip breakage while utilizing their ultrasonic aspirator. There has not been any adverse consequence to the patient, and action has been taken to prevent recurrence of the situation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1420001-1997-00006 |
| MDR Report Key | 117879 |
| Date Received | 1997-09-05 |
| Date of Report | 1997-09-05 |
| Date of Event | 1997-08-08 |
| Date Facility Aware | 1997-08-08 |
| Report Date | 1997-09-05 |
| Date Reported to FDA | 1997-09-05 |
| Date Reported to Mfgr | 1997-09-05 |
| Date Added to Maude | 1997-09-09 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | SHARPLAN ULTRASONIC ASPIRATOR TIP |
| Generic Name | ULTRASONIC ASPIRATOR ACCESSORY |
| Product Code | MGI |
| Date Received | 1997-09-05 |
| Model Number | * |
| Catalog Number | AA-264-6700 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8 MO |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 115607 |
| Manufacturer | FIBRA SONICS, INC. |
| Manufacturer Address | 5312 NORTH ELSTON AVE CHICAGO IL 60630 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-09-05 |