MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-12-07 for OPMI PENTERO 900 302582-9902-000 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[129646899]
A device evaluation was not performed because the opmi pentero 900 microscope was serviced 3 weeks prior to the incident and no issues were identified. In addition, the customer communicated that the issue was not caused due to any malfunction of the microscope.
Patient Sequence No: 1, Text Type: N, H10
[129646900]
A healthcare professional (hcp) reported that a patient received a 1st to 2nd degree burn during a spinal surgery while using an opmi pentero 900 microscope. The burn was egg-sized and within the proximity of the surgical area. The hcp treated the patient's burn with a grease pad. The hcp communicated that the issue was not as a result of any malfunction with the microscope. The hcp reported that the focus light link was purposely switched off prior to the surgery which compromised a safety measure of the microscope.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2018-00015 |
| MDR Report Key | 8143094 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-12-07 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-11-09 |
| Date Mfgr Received | 2018-11-09 |
| Device Manufacturer Date | 2013-02-08 |
| Date Added to Maude | 2018-12-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. VERNON BROWN |
| Manufacturer Street | 5160 HACIENDA DRIVE |
| Manufacturer City | DUBLIN CA 94568 |
| Manufacturer Country | US |
| Manufacturer Postal | 94568 |
| Manufacturer Phone | 9255574616 |
| 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, GENERAL & PLASTIC SURGERY |
| Product Code | FSO |
| Date Received | 2018-12-07 |
| Model Number | NA |
| Catalog Number | 302582-9902-000 |
| 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. Required No Informationntervention | 2018-12-07 |