MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-07-27 for OPMI SENSERA N/A 000000-1183-793 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[115404622]
A health care professional (hcp) reported that while the doctor was moving the opmi sensera microscope to the operating table prior to a procedure, the optical head became loose from the suspension arm. The head did not fully detach and was still connected to the arm via a cable. The doctor was supporting the head on his hand which prevented it from falling. No patient was in the room at this time. The doctor mounted the optical head back onto the stand using an allen wrench. The same microscope was used to complete the scheduled procedure with minor delay. There was no injury reported to the patient, doctor or a third party.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2018-00010 |
| MDR Report Key | 7729155 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-27 |
| Date of Report | 2018-06-28 |
| Date of Event | 2018-06-28 |
| Date Mfgr Received | 2018-06-28 |
| Device Manufacturer Date | 2002-11-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | OPMI SENSERA |
| Generic Name | MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | FSO |
| Date Received | 2018-07-27 |
| Model Number | N/A |
| Catalog Number | 000000-1183-793 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2018-07-27 |