N
Patient 1
AN INVESTIGATION OF THE INCIDENT IS CURRENTLY ONGOING AND A FOLLOW UP INCLUDING THE OUTCOME OF THE INVESTIGATION WILL BE SUBMITTED.
MAUDE MDR 5093857
- MDR report key
- 5093857
- Report number
- 8010478-2015-00006
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-07-07
- Date received
- 2015-09-22
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ROBERT GROPP
- Address
- HEIDELBERGERSTR. 17-19 NUSSLOCH, 69226 GM
- Phone
- 622-622-6224
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LEICA RM2255 | MICROTOM | LEICA BIOSYSTEMS NUSSLOCH GMBH | IDO | 1492255UL01 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-09-22 | 0 | 1. O |
Event Narratives#
D
Patient 1
ON (B)(6) 2015, THE CUSTOMER REPORTED AN INJURY USING A ROTARY MICROTOME. THE USER WAS TREATED FOR HER INJURY AT (B)(6) AND THEY WERE ABLE TO REATTACH THE END OF HER FINGER.
N
Patient 1
THIS INCIDENT WAS PRESUMABLY USER RELATED. WHILE THE USERS FINGERTIP WAS IN THE CUTTING AREA, SHE ACTIVATED THE CUTTING PROCESS BY THE FOOT PEDAL. SAFETY GLOVES WERE NOT WORN, AS DESCRIBED IN THE INSTRUCTION FOR USE: "WHEN WORKING WITH MICROTOMES, PERSONAL SAFETY PRECAUTIONS MUST ALWAYS BE TAKEN. IT IS MANDATORY TO WEAR WORK SAFETY SHOES, SAFETY GLOVES, A MASK AND SAFETY GOGGLES." A CUSTOMER FACING LETTER WILL BE SEND OUT WITH RECOMMENDATION IN FUTURE TO FOLLOW THE DESCRIPTION PROVIDED IN THE INSTRUCTION FOR USE.