MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2010-04-05 for RESEARCH CRYOSTAT LEICA CM3050 S CM3050S 14047033510 manufactured by Leica Biosystems Nussloch Gmbh.
[1645369]
On march 4, 2010, leica microsystems received a complaint that while using a cm3050 cryostat, a lab technician experienced a cut on her finger that required stitches. The cutting blade on this model of cryostat can be actuated by hand or by using a footswitch. The technician was not using the footswitch at the time and the footswitch was off to the side of the cryostat. Another tech approached her, looking over her shoulder to see what she was doing. The second technician inadvertently stepped on the foot switch, actuating the blade while the user's hand was in the cryostat.
Patient Sequence No: 1, Text Type: D, B5
[8595964]
Conclusion from investigation: no corrective action is required. Cause of problem was due to user error - user not following instructions in user manual. Reference page 9 and 10 of current operators manual requiring that the handwheel always be "locked" in a safe position before placing hands in cryostat.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010478-2010-00001 |
| MDR Report Key | 1652714 |
| Report Source | 08 |
| Date Received | 2010-04-05 |
| Date of Report | 2010-03-04 |
| Date of Event | 2010-02-22 |
| Date Mfgr Received | 2010-03-04 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2010-04-09 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | KLAUS STADTLER |
| Manufacturer Street | HEIDELBERGER STR. 17-19 |
| Manufacturer City | NUSSLOCH 6922 |
| Manufacturer Country | GM |
| Manufacturer Postal | 6922 |
| Manufacturer Phone | 224143248 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESEARCH CRYOSTAT LEICA CM3050 S |
| Generic Name | CRYOSTAT |
| Product Code | IDP |
| Date Received | 2010-04-05 |
| Model Number | CM3050S |
| Catalog Number | 14047033510 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Manufacturer Address | HEIDELBERGER STR. 17-19 NUSSLOCH 6922 GM 6922 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-04-05 |