MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-22 for PROBE,STERILE, ULTRASONIC OSCILLATING 27093LK manufactured by Karl Storz Se & Co. Kg.
[142770141]
Customer has not returned product 27093lk and has not responded to our attempts to gather further information. The sterile ultrasonic oscillating probe was shipped to the customer approximately 3 years ago.
Patient Sequence No: 1, Text Type: N, H10
[142770142]
Allegedly, the item broke in two pieces in the patient during a procedure. They were able to retrieve all broken pieces and it was reported there was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2019-00039 |
| MDR Report Key | 8538148 |
| Date Received | 2019-04-22 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-02-12 |
| Date Mfgr Received | 2019-03-25 |
| Date Added to Maude | 2019-04-22 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 EAST GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer G1 | KARL STORZ SE & CO. KG |
| Manufacturer Street | DR.-KARL-STORZ-STRASSE 34 78532 |
| Manufacturer City | TUTTLINGEN, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROBE,STERILE, ULTRASONIC OSCILLATING |
| Generic Name | OSCILLATING STERILE PROBE |
| Product Code | FEO |
| Date Received | 2019-04-22 |
| Model Number | 27093LK |
| Lot Number | 51791 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ SE & CO. KG |
| Manufacturer Address | DR.-KARL-STORZ-STRASSE 34 78532 TUTTLINGEN, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-22 |