MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-07-13 for S100 OPMI PICO 304977-9033-500 manufactured by Carl Zeiss Meditec Ag (carl Zeiss Meditec Ag (ober.
[114416885]
During the manufacturer's investigation, it was discovered that the device had been modified without authorization from the manufacturer. The s100 stand (which is normally attached to an opmi pico head) was found attached to the head from a different zeiss microscope - an opmi 1-fc. In addition, the castors attached to the base were found to be non-zeiss supplied castors. The user manual for the s100 contains clear instructions that any modification of the system is forbidden. The user manual also states that any repair work performed by untrained and/or non-certified person(s) is prohibited. Also, the recommended maintenance schedule for this device is annual servicing; however, no service/maintenance record for this device has been found by the manufacturer. Carl zeiss ltd. Communicated to the customer to take the microscope out of service.
Patient Sequence No: 1, Text Type: N, H10
[114416886]
A healthcare professional (hcp) reported that when the brake was released on the s100 microscope arm, the balance failed and the microscope head fell. It was reported by the customer that the pivot on the arm's pneumatic spring had disengaged from its mount, and hence when the brake was adjusted, the microscope head fell and was caught by the user. The user had to catch the head to avoid harm to the patient. The pneumatic arm is held in place solely by tension and is not captive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2018-00009 |
| MDR Report Key | 7688079 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-13 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-06-04 |
| Date Mfgr Received | 2018-06-13 |
| Device Manufacturer Date | 2002-06-17 |
| Date Added to Maude | 2018-07-13 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S100 OPMI PICO |
| Generic Name | OPMI PICO |
| Product Code | HRM |
| Date Received | 2018-07-13 |
| Model Number | S100 |
| Catalog Number | 304977-9033-500 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (CARL ZEISS MEDITEC AG (OBER |
| Manufacturer Address | RUDOLF-EBER-STRASSE 11 OBERKOCHEN, BADEN-WUERTTEMBERG 73447 GM 73447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-13 |