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 2018-03-16 for OPMI PENTERO 302582-9901-000 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[103163893]
At the start of a lumbar decompression surgery, the light field diameter of the pentero microscope could not be automatically or manually adjusted to an appropriate size. No other microscope nor the surgeon's loupes were available. The surgeon was able to get good decompression on the spine, but could not see well enough to cauterize a cut blood vessel. A hemostatic agent was used to stop the bleeding sufficiently to close the case. The usual 1 hour procedure lasted 4. 5 - 5 hours, during which an unplanned urinary catheterization was performed. The patient was discharged with a wound drain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2018-00005 |
| MDR Report Key | 7347052 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-16 |
| Date of Report | 2018-02-16 |
| Date of Event | 2018-02-16 |
| Date Mfgr Received | 2018-02-16 |
| Device Manufacturer Date | 2006-09-25 |
| Date Added to Maude | 2018-03-16 |
| 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 | OPMI PENTERO |
| Generic Name | MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | FSO |
| Date Received | 2018-03-16 |
| Model Number | NA |
| Catalog Number | 302582-9901-000 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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; 2. Required No Informationntervention | 2018-03-16 |