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 2016-11-21 for LEICA MDRS4 manufactured by Leica Microsystems (schweiz) Ag.
[60564601]
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
[60564602]
Leica microsystems (schweiz) ag received a complaint on (b)(6) 2016 from (b)(6) stating that in the middle of a tumor surgery, smoke came from the surgical microscope caused by a burnt recording system mdrs4 cable. The surgical microscope powered off on its own. The surgical microscope could be turned on after 5 to 10 minutes but not the recording system mdrs4. Its hard disc power supply cable was burnt. There was no patient/user harm. The surgery was completed with the same device.
Patient Sequence No: 1, Text Type: D, B5
[71017607]
This is a final report. Initial investigation (visual inspection) showed that the part, which caused the malfunction, is a medical video recorder (leica mdrs4). The unit was sent to the supplier for detailed investigation. Root cause analysis revealed that the manufacturing process for this sata power cable had a cleaning process where phosphoric acid solution was used as a cleaning agent on the gold contacts. The phosphoric acid solution wicks along the dielectric channels by capillary action, into the connector housing, and becomes entrapped in the region where the unprotected copper is susceptible to corrosive attack. An inadequate rinsing process may have occurred, incapable of removing the remaining trapped solution. Through the time, corrosion produces particle that acts as bridges, which eventually induced the electrical short-circuit resulting in the over-heating and burning of the plastic non-flammable insulation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003974370-2016-00012 |
| MDR Report Key | 6117114 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-11-21 |
| Date of Report | 2016-11-03 |
| Date of Event | 2016-10-28 |
| Date Mfgr Received | 2016-11-03 |
| Device Manufacturer Date | 2013-01-15 |
| Date Added to Maude | 2016-11-21 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEICA MDRS4 |
| Generic Name | SURGICAL MICROSCOPE ACCESSORY |
| Product Code | EPT |
| Date Received | 2016-11-21 |
| Model Number | MDRS4 |
| 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 | 2016-11-21 |