MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-07-05 for CLINICUT 60 CRYOSTAT * manufactured by Hacker Instruments & Industries.
[245834]
Rptr was trying to secure the button into the specimen holder, which required some force to snap-in to the slot. During this maneuver, their fingers slipped from the button and hit the knife blade, resulting in a cut on right middle finger. Compared to other cryostats, this particular model requires snap-in holder of the button and has a large portion of the blade being exposed to give a potential for cutting injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1022337 |
| MDR Report Key | 340960 |
| Date Received | 2001-07-05 |
| Date of Report | 2001-07-05 |
| Date of Event | 2001-04-03 |
| Date Added to Maude | 2001-07-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLINICUT 60 CRYOSTAT |
| Generic Name | MICROTOME CRYOSTAT |
| Product Code | IDN |
| Date Received | 2001-07-05 |
| Model Number | CLINICUT 60 CRYOSTAT |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 330287 |
| Manufacturer | HACKER INSTRUMENTS & INDUSTRIES |
| Manufacturer Address | 17 SHERWOOD LANE PO BOX 10033 FAIRFIELD NJ 07004 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-07-05 |