MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-08-15 for LEICA M530 OHX manufactured by Leica Microsystems (schweiz) Ag.
[83009974]
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
[83009975]
Leica microsystems received a complaint on (b)(6) 2017 from (b)(6) stating that the main light failed during surgery. When switching to the back-up illumination, it did not work. The system was switched off and on again. After the restart, both lamps did work. There was no patient injury reported. The surgery was completed with the same device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003974370-2017-00009 |
| MDR Report Key | 6796384 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-15 |
| Date of Report | 2017-12-11 |
| Date of Event | 2017-07-18 |
| Date Mfgr Received | 2017-07-18 |
| Device Manufacturer Date | 2016-12-09 |
| Date Added to Maude | 2017-08-15 |
| 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, 9435 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 9435 |
| Manufacturer G1 | LEICA INSTRUMENTS (SINGAPORE) PTE LTD |
| Manufacturer Street | 12 TEBAN GARDENS CRESCENT |
| Manufacturer City | 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 M530 OHX |
| Generic Name | SURGICAL MICROSCOPE |
| Product Code | EPT |
| Date Received | 2017-08-15 |
| 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, 9435 SZ 9435 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-15 |