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 2017-04-27 for LEICA M525 F20 manufactured by Leica Microsystems (schweiz) Ag.
[74145953]
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
[74145954]
Leica microsystems (b)(6) received a complaint on april 10, 2017 from (b)(6) stating that during an endodontic surgery, the user heard a noise coming from the stand. The lamp went out. As there was only one lamp mounted, the microscope had no light at all. The procedure was completed with another microscope.
Patient Sequence No: 1, Text Type: D, B5
[75938091]
The affected part was not returned to the manufacturer because it has been discarded by the dealer's engineer. Therefore, an evaluation cannot be performed and the device's problem cannot be confirmed. Affected part has been discarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003974370-2017-00006 |
| MDR Report Key | 6525788 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-27 |
| Date of Report | 2017-04-10 |
| Date of Event | 2017-04-09 |
| Date Mfgr Received | 2017-04-10 |
| Device Manufacturer Date | 2012-06-27 |
| Date Added to Maude | 2017-04-27 |
| 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 | HEERBRUGG, 9435 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 9435 |
| Manufacturer Phone | 717263216 |
| 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 M525 F20 |
| Generic Name | SURGICAL MICROSCOPE |
| Product Code | EPT |
| Date Received | 2017-04-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-04-27 |