MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-08-25 for LEICA MICROSYSTEMS M525 OH4 manufactured by Leica Microsystems (schweiz) Ag.
[52950603]
An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.
Patient Sequence No: 1, Text Type: N, H10
[52950604]
Leica microsystems (b)(4) received a complaint on (b)(6) 2016 from usa stating that a leica m525 oh4 surgical microscope caught fire and according to the university bio-med, the recording system (b)(4) may have been the component that caught fire and caused smoke to appear. The operating room staff moved the microscope system out of the field and used another microscope to perform the surgery. There was no patient/user injury reported and no further information is as yet available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003974370-2016-00009 |
| MDR Report Key | 5903051 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-08-25 |
| Date of Report | 2016-08-01 |
| Date of Event | 2016-08-01 |
| Date Added to Maude | 2016-08-25 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROLAND JEHLE |
| Manufacturer Street | MAX SCHMIDHEINY STRASSE 201 |
| Manufacturer City | HEERBRUG, ST. GALLEN 9435 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 9435 |
| Manufacturer Phone | 1717263216 |
| Manufacturer G1 | LEICA MICROSYSTEMS (SCHWEIZ) AG |
| Manufacturer Street | MAX SCHMIDHEINY STRASSE 201 |
| Manufacturer City | HEERBRUGG, ST. GALLEN 9435 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 9435 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA MICROSYSTEMS |
| Generic Name | LEICA M525 OH4 |
| Product Code | EPT |
| Date Received | 2016-08-25 |
| Model Number | M525 OH4 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA MICROSYSTEMS (SCHWEIZ) AG |
| Manufacturer Address | MAX SCHMIDHEINY STRASSE 201 HEERBRUGG, ST. GALLEN 9435 SZ 9435 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-08-25 |