MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-07-27 for LEICA M530 OH6 manufactured by Leica Microsystems (schweiz) Ag.
[115183799]
(b)(4). An investigation of the incident is currently underway and a follow-up will be submitted should additional information become available following investigation.
Patient Sequence No: 1, Text Type: N, H10
[115183800]
On (b)(6) 2018, leica microsystems (b)(6) received a complaint from the usa stating that three (3) patients had skin ulcerations and one (1) patient had thermal burn immediately following surgery. For this report one patient had thermal burn immediately following surgery. See manufacturer/importer report numbers: 3003974370-2018-00007 / 3003974370-2018-00008 / 3003974370-2018-00009 for information regarding the other three (3) patients reported in the complaint.
Patient Sequence No: 1, Text Type: D, B5
[119711740]
(b)(4). This is a final report. Leica microsystems (b)(4) performed visual inspection and functional test on the actual device. The results were as follows: the m530 oh6 has brightcare protection installed which reduces the light intensity automatically as the working distance decreases. This minimizes potential incidents of patient burns. This system engages by default upon microscope startup. The brightcare system was shown to be active upon examination and functioning properly. All filters were in the proper location within the m530 oh6 and were shown to be functioning correctly. An examination of the infrared (ir) heat protection filter showed, that the ir filter of the m530 oh6 functioned according to specifications. A check of the device history record showed that the device was functioning according to specifications and revealed no anomalies during manufacturing, in-process controls and final acceptance test. A review of the complaint databank showed, that leica microsystems (b)(4) is not aware of any other similar incident since introduction of the m530 oh6. Based on the investigation results and the review of the complaint databank we conclude, that the m530 oh6 functions correctly and that it is highly unlikely that it caused or contributed to the incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003974370-2018-00010 |
| MDR Report Key | 7725440 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-07-27 |
| Date of Report | 2018-09-10 |
| Date of Event | 2018-06-11 |
| Date Facility Aware | 2018-07-02 |
| Date Mfgr Received | 2018-07-02 |
| Device Manufacturer Date | 2017-08-14 |
| Date Added to Maude | 2018-07-27 |
| 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 |
| 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, SANKT GALLEN 9435 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 9435 |
| Manufacturer G1 | LEICA INSTRUMENTS (SINGAPORE) PTE LTD |
| Manufacturer Street | 12 TEBAN GARDENS CRESCENT |
| Manufacturer City | SINGAPORE, 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 M530 OH6 |
| Generic Name | SURGIAL MICROSCOPE |
| Product Code | EPT |
| Date Received | 2018-07-27 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 11 MO |
| 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, SANKT GALLEN 9435 SZ 9435 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-27 |