MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-01-30 for LEICA DM 2000 11888138 manufactured by Leica Microsystems Cms Gmbh.
[984183]
Technician touched focus knob with one hand while her other hand was on the condenser and allegedly received a shock. The technician reportedly felt burning and numbness in her hand and was going to see a neurologist. It is unknown if the technician visited a neurologist and any medical intervention was required. The microscope was plugged into a leica light source. Investigation showed that the microscope originally was not connected to the mains supply as it is used only for reflected light fluorescence with external light source. It was decided to plug it in for proper grounding. Biomedical department personnel onsite tested the unit and concluded a leakage current at. 75ma which is within limits of acceptance. Event description indicates that the device did not contribute to serious injury or death and further investigation will be conducted in respect to potential build up of static shock.
Patient Sequence No: 1, Text Type: D, B5
[8155873]
During interviews conducted with the customer during the investigation, it was communicated that the hospital's biomedical engineers had tested the leakage from the instrumentation and it meets the csa electrical standards. They said the leakage was not enough to cause a shock. Additionally, the safety documentation in the operating manual status that any interruption of the ground wire inside or outside of the device, or release of the ground wire connection can cause the device to become hazardous. The stand was not plugged in at the time of the shock and, therefore, it was not grounded. The biomedical engineers have now connected an isolation transformer into the electrical wall outlet to plug the microscope power cable into it. Because leica technical service personnel and their biomedical engineers could not find a reason why the lab technician received a shock, the microscope and system are being sent from the customer to another country's mfr to conduct further testing. They have been provided a replacement in the interim. Their equipment will be returned to service at the hospital following the manufacturer's investigation. Comparable system evaluated at factory: no product failures detected.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003893952-2009-00001 |
| MDR Report Key | 1302226 |
| Report Source | 07 |
| Date Received | 2009-01-30 |
| Date of Report | 2008-12-31 |
| Date of Event | 2008-12-30 |
| Date Mfgr Received | 2008-12-31 |
| Device Manufacturer Date | 2008-06-01 |
| Date Added to Maude | 2009-02-09 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | HOLGER GRASSE |
| Manufacturer Street | ERNST-LEITZ-STRASSE 17-37 |
| Manufacturer City | WETZLAR 35578 |
| Manufacturer Country | GM |
| Manufacturer Postal | 35578 |
| Manufacturer Phone | 441292707 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA DM 2000 |
| Generic Name | FLOURESCENCE MICROSCOPE |
| Product Code | IBK |
| Date Received | 2009-01-30 |
| Model Number | DM 2000 |
| Catalog Number | 11888138 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA MICROSYSTEMS CMS GMBH |
| Manufacturer Address | ERNST-LEITZ-STRASSE 17-37 WETZLAR 35578 35578 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-01-30 |