MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-09 for ZEISS OPMI PENTERO 900 manufactured by Carl Zeiss Meditec, Inc..
[114409805]
During surgery to repair hand after a trauma incident, the pt experienced a burn to the palm of hand as a result of the microscope light. The pt's adipose tissue was exposed to the light from the microscope for less than 20 mins of time. This burn was determined to be a full thickness burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7698589 |
| MDR Report Key | 7698589 |
| Date Received | 2018-07-09 |
| Date of Report | 2018-07-06 |
| Date of Event | 2018-02-01 |
| Date Facility Aware | 2018-02-01 |
| Report Date | 2018-07-06 |
| Date Reported to FDA | 2018-07-06 |
| Date Reported to Mfgr | 2018-07-06 |
| Date Added to Maude | 2018-07-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ZEISS |
| Generic Name | SURGICAL MICROSCOPE |
| Product Code | EPT |
| Date Received | 2018-07-09 |
| Model Number | OPMI PENTERO 900 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 15 MO |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC, INC. |
| Manufacturer Address | DUBLIN CA 94568 US 94568 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-09 |