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 2018-09-06 for OPMI CS N/A 302503-0000-000 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[119488891]
During inspection of the device the customer informed a czmi field service engineer that during the case, the light intensity of the microscope was set at near maximum. The user manual describes that a long duration of treatment especially in combination with high light intensity can lead to skin burn.
Patient Sequence No: 1, Text Type: N, H10
[119488892]
A health care professional (hcp) reported that a patient sustained a burn after undergoing a 90-120 minutes of left post-auricular underlay tympanoplasty procedure with the opmi cs surgical microscope. The burn was described as second degree and involved most of the pinna. The hcp used silver sulfadiazine at end of the surgery to treat the patient and wrapped the ear in glasscock dressing. It was further reported that the patient had been subsequently evaluated and treated by a burn clinic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2018-00012 |
| MDR Report Key | 7853578 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-06 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-08-06 |
| Date Mfgr Received | 2018-08-08 |
| Date Added to Maude | 2018-09-06 |
| 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 | 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 CS |
| Generic Name | MICROSCOPE, SURGICAL |
| Product Code | EPT |
| Date Received | 2018-09-06 |
| Model Number | N/A |
| Catalog Number | 302503-0000-000 |
| Lot Number | N/A |
| 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 MICHAEL.SCHMIDT@ZEISS.COM OBERKOCHEN, BADEN-WUERTTEMBERG 73447 GM 73447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-06 |