MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-04-12 for LEICA MICROSYSTEMS M525 F50 manufactured by Leica Microsystems.
[42437824]
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
[42437825]
Leica microsystems ((b)(4)) received a complaint on the (b)(6) 2016 from (b)(6) stating that the fuse of the main switch on a leica m525 f50 surgical microscope system blew during surgery. The surgeon continued the surgery by replacing the fuse during the procedure and therefore he was able to complete successfully the case by using the affected device. There was no patient/user harm reported.
Patient Sequence No: 1, Text Type: D, B5
[46443260]
This is a final report. An investigation on a representative sample has been performed by the specification developer due to the fact that no parts were returned. Based on theoretical analysis and tests performed by the specification developer the results show that the reported malfunction was caused by the main fuse of the system which tripped. The exact root cause of the blown fuse could not be determined because the reported malfunction was not reproducible. According to theoretical analysis it is most likely that over a long time voltage spikes on the main line triggered the voltage dependend resistor (vdr) in the unit, which became low impedance and thus triggered the fuse. Or the main fuse has been pre-damaged in the past by an overcurrent. Based on a review of the complaint statistic the probability of occurrence is evaluated as remote and the event has been considered as an isolated event. The affected device is still in use and needs not be repaired because the or staff replaced the fuse already during surgery and device works according to specification.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003974370-2016-00006 |
| MDR Report Key | 5570287 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-04-12 |
| Date of Report | 2016-04-01 |
| Date of Event | 2016-03-28 |
| Date Added to Maude | 2016-04-12 |
| 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 | 12 TEBAN GARDENS CRESCENT |
| Manufacturer City | SINGAPORE, 608924 |
| Manufacturer Country | SN |
| Manufacturer Postal | 608924 |
| Manufacturer Phone | 1717263216 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA MICROSYSTEMS |
| Generic Name | LEICA M525 F50 |
| Product Code | EPT |
| Date Received | 2016-04-12 |
| Model Number | M525 F50 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LEICA MICROSYSTEMS |
| Manufacturer Address | MAX SCHMIDHEINY STRASSE 201 HEERBRUGG,, ST. GALLEN 9435 SZ 9435 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-12 |