FDA Adverse Event
Other
Summary report: N
KARL STORZ ENDOVISION
MDR report key: 633328
·
Received September 2, 2005
Report
- Report Number
- 2020550-2005-00017
- Event Type
- Other
- Date Received
- September 2, 2005
- Date of Event
- July 22, 2005
- Report Date
- August 31, 2005
- Manufacturer
- KARL STORZ
- Product Code
- FFZ
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ ENDOVISION | LIGHT CABLE | FFZ | KARL STORZ | 495NCS | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |