MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-03-08 for OPMI PICO ON S100 WALL MOUNT 000000-1403-544 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[101993274]
The manufacture made attempts to access the microscope system for evaluation without success. Based on pictures provided by the hcp, the manufacturer determined the root cause of the malfunction to be incorrect screw or/and wall plug which was used to install the wall mount plate to the wall. The hcp informed the manufacturer that the microscope system was removed from its original installation site and was mounted at a different location. The reinstallation was performed by a 3rd party service provider.
Patient Sequence No: 1, Text Type: N, H10
[101993275]
A healthcare professional (hcp) reported that the supporting wall mount plate, on which the opmi pico with s100 wall mount microscope system was mounted, came loose from the wall and the microscope system dropped on a bed below. The incident happened after the surgery had already been completed. No one was using the microscope at the time and no patient was involved. There was no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2018-00003 |
| MDR Report Key | 7325842 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-03-08 |
| Date of Report | 2018-02-07 |
| Date of Event | 2018-02-07 |
| Date Mfgr Received | 2018-02-07 |
| Device Manufacturer Date | 2012-10-31 |
| Date Added to Maude | 2018-03-08 |
| 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. WILLIAM GUSTAFSON |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574689 |
| Manufacturer G1 | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Street | RUDOLF-EBER-STRASSE 11 |
| Manufacturer City | OBERKOCHEN, BADEN-WUERTTEMBERG 73447 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 73447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPMI PICO ON S100 WALL MOUNT |
| Generic Name | MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | FSO |
| Date Received | 2018-03-08 |
| Model Number | NA |
| Catalog Number | 000000-1403-544 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Address | RUDOLF-EBER-STRASSE 11 OBERKOCHEN, BADEN-WUERTTEMBERG 73447 GM 73447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-08 |