MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-04-01 for MICROM HM355S-3 905200 manufactured by Microm International Gmbh.
[1851613]
On (b)(6) 2011, a technician was routinely cutting blocks. The tech pressed the stop button on the console and the chuck came to the top and paused. As it paused, the tech grasped the block to remove it from the chuck and the chuck then allegedly began to move. This resulted in injury to the tech in the form of a laceration to the index finger and thumb. The tech was treated and intervention was required to prevent permanent damage. Company was notified on (b)(6) 2011. Two safety features exist to prevent this type of injury as detailed in the instructions for use. These features include a manual brake which prevents the wheel and chuck from moving and a physical guard that is placed over the knife during block changes. Neither safety feature was employed by the user in this case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002985827-2011-00001 |
| MDR Report Key | 2058926 |
| Report Source | 07 |
| Date Received | 2011-04-01 |
| Date of Report | 2011-03-03 |
| Date of Event | 2011-02-11 |
| Date Mfgr Received | 2011-03-03 |
| Device Manufacturer Date | 2010-11-18 |
| Date Added to Maude | 2011-04-19 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANGIE KILGORE |
| Manufacturer Street | 4481 CAMPUS DR |
| Manufacturer City | KALAMAZOO MI 49008 |
| Manufacturer Country | US |
| Manufacturer Postal | 49008 |
| Manufacturer Phone | 2695445628 |
| Manufacturer G1 | MICROM INTERNATIONAL 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 | 2011-04-01 |
| Returned To Mfg | 2011-03-23 |
| Model Number | HM355S-3 |
| Catalog Number | 905200 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROM INTERNATIONAL GMBH |
| Manufacturer Address | WALLDORF GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-04-01 |