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 2017-12-26 for OPMI PENTERO 800 302582-9903-000 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[95774296]
The different factors that can influence the risk of burn injuries are described in detail in the user manual (g-30-1458-en, issue 9. 1). Recommendations for reducing the risk of burns are also included.
Patient Sequence No: 1, Text Type: N, H10
[95774297]
The health care professional (hcp) reported that a head and neck cancer patient sustained a burn after a flap surgery in which the opmi pentero microscope was used. The microscope light intensity setting was at 87% and threshold value light warning was at 81%. In the first half hour of the three hours surgery, the hcp recognized that the vein had dried on the patient's neck. An abundant irrigation was performed with serum physiology as an after treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2017-00019 |
| MDR Report Key | 7146459 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-12-26 |
| Date of Report | 2017-11-27 |
| Date of Event | 2017-11-15 |
| Date Mfgr Received | 2017-11-27 |
| Device Manufacturer Date | 2017-01-23 |
| Date Added to Maude | 2017-12-26 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPMI PENTERO 800 |
| Generic Name | MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | FSO |
| Date Received | 2017-12-26 |
| Model Number | 800 |
| Catalog Number | 302582-9903-000 |
| 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 | 1. Required No Informationntervention | 2017-12-26 |