MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-09 for KARL STORZ ULTRASONIC OSCILLATING BURR TIP 27093LL manufactured by Karl Storz Endoscopy - America, Inc..
[127254454]
During a left percutaneous nephrolithotomy, the tip of the sterile disposable ultrasonic oscillating burr tip broke off in pt's kidney. The surgeon was able to remove the tip from the kidney. A new sterile probe was opened and the procedure was completed successfully. Defective device caused unsafe condition. No harm to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081238 |
| MDR Report Key | 8070700 |
| Date Received | 2018-11-09 |
| Date of Report | 2018-11-02 |
| Date of Event | 2018-10-23 |
| Date Added to Maude | 2018-11-14 |
| 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 | RISK MANAGER |
| 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 | KARL STORZ ULTRASONIC OSCILLATING BURR TIP |
| Generic Name | LITHOTRIPTOR, ULTRASONIC |
| Product Code | FEO |
| Date Received | 2018-11-09 |
| Model Number | 27093LL |
| Lot Number | 53071 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ ENDOSCOPY - AMERICA, INC. |
| Manufacturer Address | EL SEGUNDO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-09 |