MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-28 for ULTRASONIC LITHOTRIPSY PROBE WITH OSCILLATING BURR TIP 27093LK manufactured by Karl Storxz Se & Kg.
[140431935]
The tip broke approximately 2" from where the tip is threaded into the hand held motor portion. User noticed loss of suction while in use, pulling the motor from the sheath user noticed there was only a portion of the burr still attached to the motor. The rest of the burr was still in the sheath and we were able to retrieve it because a portion was sticking ou the sheath.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085354 |
| MDR Report Key | 8465428 |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-02-12 |
| Date Added to Maude | 2019-03-29 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ULTRASONIC LITHOTRIPSY PROBE WITH OSCILLATING BURR TIP |
| Generic Name | ULTRASONIC LITHOTRIPSY PROBE |
| Product Code | FEO |
| Date Received | 2019-03-28 |
| Returned To Mfg | 2019-03-25 |
| Model Number | 27093LK |
| Lot Number | 51791 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORXZ SE & KG |
| Manufacturer Address | EL SEGUNDO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-28 |