MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-23 for ILLUMINATED URETER PROBE 496U manufactured by Karl Storz Se & Co. Kg.
[124790362]
Our local sales rep was informed that a patient received a burn to the leg that blistered. We have not been able to obtain any further details of this event. We suspect that the most likely cause of the burn injury was that the illuminated ureter probe connector, which is connected to a light cable, came into contact with the patient. Our ifu warns against attaching light cables to the patient or drape. The illuminated ureter probe was not returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[124790363]
Allegedly, during a procedure, the patient's leg was burned by the proximal end of the ureter probe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2018-00085 |
| MDR Report Key | 7997853 |
| Date Received | 2018-10-23 |
| Date of Report | 2018-09-18 |
| Date Mfgr Received | 2018-09-18 |
| Date Added to Maude | 2018-10-23 |
| 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 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| 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 | ILLUMINATED URETER PROBE |
| Generic Name | ILLUMINATED URETER PROBE |
| Product Code | FCS |
| Date Received | 2018-10-23 |
| Model Number | 496U |
| Catalog Number | 496U |
| 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 | 2018-10-23 |