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 2017-05-04 for OPMI PICO ON S100 FLOOR STAND 000000-1095-102 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[74509907]
A zeiss field service engineer (fse) performed an on-site inspection and found that the screw mechanism that holds the optical head of the microscope safely to the stand was missing. The fse re-secured the optical head onto the stand with the screw mechanism and put the microscope back into service. The manufacturer reviewed the device installation process and procedures. The policies and procedures established for regular training and control of qualifications for installation and service related activities are adequate. The manufacturer concluded that the root cause of the optical head falling is improper installation performed by a non-trained person of the locally authorized distributor. The distributor was notified in writing about the unauthorized installation. The user manual (g-30-1781-en, version 7. 1, 2016-03-09, page 13) states "a zeiss service representative or an expert authorized by zeiss will install the system".
Patient Sequence No: 1, Text Type: N, H10
[74509908]
The healthcare professional (hcp) reported that during examination of a patient's ear the optical head of the opmi pico on a s100 floor stand became completely loose and fell off. The microscope head made contact with the patient's head resulting in a minor bruise. There was no medical treatment required for the patient. The doctor mounted the optical head back onto the stand and completed the procedure successfully with the same microscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2017-00005 |
| MDR Report Key | 6546625 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-04 |
| Date of Report | 2017-05-04 |
| Date of Event | 2017-04-04 |
| Date Mfgr Received | 2017-04-04 |
| Device Manufacturer Date | 2016-09-26 |
| Date Added to Maude | 2017-05-04 |
| 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 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPMI PICO ON S100 FLOOR STAND |
| Generic Name | SURGICAL MICROSCOPE |
| Product Code | FSO |
| Date Received | 2017-05-04 |
| Model Number | NA |
| Catalog Number | 000000-1095-102 |
| 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 (OBERKOCHEN) |
| Manufacturer Address | RUDOLF-EBER-STRASSE 11 OBERKOCHEN, BADEN-WUERTTEMBERG 73447 GM 73447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-04 |