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 2017-03-15 for LEICA M525 F50 10448422 manufactured by Leica Microsystems (schweiz) Ag.
[69957100]
This is a combined initial and final report. According to the field service engineer's report, the user started the surgical procedure with the auxiliary (back-up) lamp with the knowledge that the main lamp was defective. During surgery, the used auxiliary lamp malfunctioned and as a result, the surgical microscope did not have any light at all. The surgical procedure was completed by another surgical microscope. As a result of the malfunction of both main and auxiliary lamps, a field service engineer (fse) was requested on site to repair the affected components. During repair, fse's analysis showed that the malfunction of the main lamp was caused by a defective ignitor and the malfunction of the auxiliary lamp was caused by a defective xenon power supply board. Further investigation was conducted by the manufacturer. The instructions for use was reviewed and it states that during preparation and prior to surgery, the main and auxiliary lamps shall undergo a function check to ensure that both lamps (main and auxiliary) are functioning. In addition, the timer for the xenon lamps shall be checked as well. However, the user continued to use the surgical microscope with a defective main lamp. In addition, the user failed to have the defective main lamp replaced and repaired during preparation and prior to surgery. Therefore, the manufacturer concludes that the incident was caused by use error, failure to service and failure to follow the manufacturer's instructions.
Patient Sequence No: 1, Text Type: N, H10
[69957101]
On (b)(6) 2017, leica microsystems received a complaint stating that during a surgical procedure, both the xenon illumination of leica m525 f50 malfunctioned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003974370-2017-00003 |
| MDR Report Key | 6405363 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-15 |
| Date of Report | 2017-02-15 |
| Date of Event | 2017-02-15 |
| Date Mfgr Received | 2017-02-15 |
| Date Added to Maude | 2017-03-15 |
| 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, 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 PROCEDURE |
| Product Code | EPT |
| Date Received | 2017-03-15 |
| Model Number | M525 F50 |
| Catalog Number | 10448422 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Other | 2017-03-15 |