MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-02 for KARL STORZ ENDOVISION 495NCS manufactured by Karl Storz.
[434767]
Patient underwnet a cysto-ureteroscopy procedure. After the procedure, during recovery, the pt complained about pain on their hand and at that time a burn on the pt's right hand in the area between the index finger and thumb was observed. A plastic surgeon was called to examine it and a surgery to remove the burned skin was done in 07/05 and the pt was discharged the next day. The hospital suspects the burn was caused as result of the light cable being detached from the telescope, then laid across the pt's chest and left on the hand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020550-2005-00017 |
| MDR Report Key | 633328 |
| Date Received | 2005-09-02 |
| Date of Report | 2005-08-31 |
| Date of Event | 2005-07-22 |
| Date Facility Aware | 2005-08-15 |
| Report Date | 2005-08-31 |
| Date Reported to FDA | 2005-08-31 |
| Date Added to Maude | 2005-09-07 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | KARL STORZ ENDOVISION |
| Generic Name | LIGHT CABLE |
| Product Code | FFZ |
| Date Received | 2005-09-02 |
| Model Number | 495NCS |
| Catalog Number | 495NCS |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 622892 |
| Manufacturer | KARL STORZ |
| Manufacturer Address | 91 CARPENTER HILL RD. CHARLTON MA 01507 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-09-02 |