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 2017-10-13 for OPMI PENTERO 900 302582-9902-000 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[89308252]
Based on available information a direct link between the blocked brakes and patient's injury and death cannot be determined. The evaluation of the device is in process. A follow up report will be submitted upon completion of the manufacturer's device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[89308253]
The health care professional (hcp) reported that the opmi pentero 900 was being used in a brain surgery to remove a large meningioma (tumor). After more than 8 hours into the procedure, the electrical opmi brakes of the opmi pentero 900 blocked. The surgeon tried to manually move the blocked opmi brakes. In the process, the surgeon accidently touched the retractor (non-zeiss device) that was positioned in the patient's brain to hold the left frontal lobe. The movement of the retractor caused the middle brain artery to be pulled out. According to the surgeon it was not possible to repair this injury. As a consequence of this injury the patient suffered a stroke on (b)(6), 2017 and died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2017-00010 |
| MDR Report Key | 6949474 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-13 |
| Date of Report | 2017-09-15 |
| Date of Event | 2017-09-05 |
| Date Mfgr Received | 2017-09-15 |
| Device Manufacturer Date | 2014-03-10 |
| Date Added to Maude | 2017-10-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 900 |
| Generic Name | MICROSCOPE, SURGICAL |
| Product Code | EPT |
| Date Received | 2017-10-13 |
| Model Number | 900 |
| Catalog Number | 302582-9902-000 |
| Lot Number | NA |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Address | RUDOLF-EBER-STRASSE 11 OBERKOCHEN, BADEN-WUERTTEMBERG 73447 GM 73447 |
| Brand Name | OPMI PENTERO 900 |
| Generic Name | MICROSCOPE, SURGICAL |
| Product Code | FSO |
| Date Received | 2017-10-13 |
| Model Number | 900 |
| Catalog Number | 302582-9902-000 |
| Lot Number | NA |
| Operator | PHYSICIAN |
| 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. Death | 2017-10-13 |