MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-01 for LEKSELL SELECTOR ULTRASONIC ASPIRATOR 24 KHZ NEURO SHORT 1523000M7 manufactured by Elekta Instruments, Inc..
[20157413]
During surgery, the tip of a handpiece (24 khz neuro short) broke off. The surgeon was performing a "re-do" brain tumor with the power setting on the console at 90%. The handpiece was vibrating as expected, when approx 1" of the tip broke off. The surgeon retrieved the broken tip and finished the surgery with the long neuro handpiece with no further incident. No harm to the pt was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037831-1996-00006 |
| MDR Report Key | 34196 |
| Date Received | 1996-07-01 |
| Date of Report | 1996-07-01 |
| Date of Event | 1996-06-27 |
| Date Facility Aware | 1996-06-27 |
| Report Date | 1996-07-01 |
| Date Reported to FDA | 1996-07-01 |
| Date Reported to Mfgr | 1996-06-27 |
| Date Added to Maude | 1996-07-19 |
| 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 | LEKSELL SELECTOR ULTRASONIC ASPIRATOR |
| Generic Name | ULTRASONIC ASPIRATOR |
| Product Code | MGI |
| Date Received | 1996-07-01 |
| Model Number | 24 KHZ NEURO SHORT |
| Catalog Number | 1523000M7 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 35556 |
| Manufacturer | ELEKTA INSTRUMENTS, INC. |
| Manufacturer Address | NEWBURY RD, ANDOVER HAMPSHIRE UK SP1O4DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-07-01 |