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 2016-12-22 for LEICA M525 F50 manufactured by Leica Microsystems (schweiz) Ag.
[63073429]
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
[63073430]
Leica microsystems (b)(4) received a complaint on (b)(6) 2016 from (b)(6) stating that in the middle of a surgical procedure, both main and back-up illumination lamps of the leica m525 f50 surgical microscope did not work. The surgeon had to stop the surgery and called the biomedical staff for assistance. The biomedical staff confirmed that both xenon lamp ignitors malfunctioned and the surgical microscope was repaired. The surgical microscope was used again to complete the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003974370-2016-00013 |
| MDR Report Key | 6197931 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-13 |
| Date of Event | 2016-12-12 |
| Date Mfgr Received | 2016-12-13 |
| Device Manufacturer Date | 2015-07-16 |
| Date Added to Maude | 2016-12-22 |
| 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, ST. GALLEN 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA M525 F50 |
| Generic Name | SURGICAL MICROSCOPE |
| Product Code | EPT |
| Date Received | 2016-12-22 |
| Model Number | M525 F50 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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, ST. GALLEN 9435 SZ 9435 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-22 |