MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-08 for LEICA M400E manufactured by Leica Microsystems (schweiz) Ag.
[138269909]
An investigation of the incident is currently underway and a follow-up will be submitted should additional information become available following investigation.
Patient Sequence No: 1, Text Type: N, H10
[138269910]
Leica microsystems (b)(4) received a complaint from (b)(6) stating that during surgery the light source of the m400e xenon overheated which caused a burning smell. Both lamps, main and back-up illumination, were no longer functional. There was no patient injury reported. The surgery was completed with another device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003974370-2019-00001 |
| MDR Report Key | 8402665 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-08 |
| Date of Report | 2019-03-21 |
| Date of Event | 2019-02-14 |
| Date Mfgr Received | 2019-02-15 |
| Device Manufacturer Date | 2008-03-12 |
| Date Added to Maude | 2019-03-08 |
| 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 |
| 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 | HEERBRUGG, SANKT GALLEN 9435 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 9435 |
| Manufacturer G1 | LEICA INSTRUMENTS (SINGAPORE) PTE LTD |
| Manufacturer Street | 12 TEBAN GARDENS CRESCENT |
| Manufacturer City | SINGAPORE, SINGAPORE 608924 |
| Manufacturer Country | SN |
| Manufacturer Postal Code | 608924 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA M400E |
| Generic Name | SURGIAL MICROSCOPE |
| Product Code | EPT |
| Date Received | 2019-03-08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA MICROSYSTEMS (SCHWEIZ) AG |
| Manufacturer Address | MAX-SCHMIDHEINY-STRASSE 201 HEERBRUGG, SANKT GALLEN 9435 SZ 9435 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-08 |