FDA Adverse Event
Injury
Summary report: N
LEICA CM1850
MDR report key: 11854256
·
Received May 20, 2021
Report
- Report Number
- 8010478-2021-00006
- Event Type
- Injury
- Date Received
- May 20, 2021
- Date of Event
- April 22, 2021
- Report Date
- May 20, 2021
- Manufacturer
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Product Code
- IDP
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE UNIT HAS BEEN EVALUATED BY A LEICA FIELD SERVICE ENGINEER. THE INVESTIGATION REVEALED THE FOLLOWING: THE ROOT CAUSE WAS DETERMINED TO BE WORN BEARINGS. THE CUSTOMER REPORTED THAT A 3RD PARTY SERVICE ENGINEER OBSERVED WORN BALL BEARINGS IN THE PRESSURE PLATE, WHICH HAS LIKELY CAUSED SECTIONING ISSUES. THE CUSTOMER DECLINED A LEICA SERVICE VISIT, AND IS AWAITING A NEW CRYOSTAT CURRENTLY ON BACKORDER.
Description of Event or Problem · 1
ON (B)(6) 2021, LEICA BIOSYSTEMS RECEIVED A COMPLAINT THAT A TISSUE SAMPLE WAS LOST DURING THE CUTTING WITH THE INSTRUMENT LEICA CM1850. AS A RESULT FOR ONE PATIENT A REBIOPSY HAS BEEN RECOMMENDED. WE ATTEMPTED TO OBTAIN PATIENT IDENTIFIER INFORMATION BUT THE CUSTOMER HAS NOT RESPONDED TO OUR INQUIRIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 752658 | LEICA CM1850 | LEICA CM1850 | IDP | LEICA BIOSYSTEMS NUSSLOCH GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |