MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-04-06 for MICROM HM355S-3 905200 manufactured by Microm Intl. Gmbh.
[17147153]
On (b)(6) 2011, a technician was routinely cutting blocks. The tech was removing the block from the chuck holder. The red emergency button was engaged on the instrument. This did not lock the handwheel because the emergency stop is only designed to halt operation during automatic (powered) mode and is not intended to lock the wheel during manual (unpowered) mode. This resulted in an injury to the tech in the form of a laceration to the finger. The tech was treated and intervention was required in the form of stitches. Company was notified on (b)(6) 2011. Two safety features are explained in the instructions for use to prevent this type of injury from occurring. These features include a manual brake which prevents the handwheel and chuck from moving and a safety bracket that is to be placed over the knife during block changes. Neither safety guard was employed by the user in this case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002985827-2011-00002 |
| MDR Report Key | 2062411 |
| Report Source | 05 |
| Date Received | 2011-04-06 |
| Date of Report | 2011-03-24 |
| Date of Event | 2011-03-10 |
| Date Mfgr Received | 2011-03-24 |
| Device Manufacturer Date | 2009-08-27 |
| Date Added to Maude | 2011-04-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANGIE KILGORE |
| Manufacturer Street | 4481 CAMPUS DRIVE |
| Manufacturer City | KALAMAZOO MI 49008 |
| Manufacturer Country | US |
| Manufacturer Postal | 49008 |
| Manufacturer G1 | MICROM INTL. GMBH |
| Manufacturer Street | OTTO-HAHN-STRASSE 1A |
| Manufacturer City | WALLDORF 69190 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 69190 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROM |
| Generic Name | MICROTOME |
| Product Code | IDL |
| Date Received | 2011-04-06 |
| Model Number | HM355S-3 |
| Catalog Number | 905200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROM INTL. GMBH |
| Manufacturer Address | WALLDORF GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-04-06 |