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 2017-12-10 for OPMI PENTERO 302582-9901-000 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[94347225]
The different factors that can influence the risk of burn injuries are described in detail in the opmi pentero user manual (g-30-1458-en, issue 9. 1, pages 22-24). Recommendations for reducing the risk of burns are also provided.
Patient Sequence No: 1, Text Type: N, H10
[94347226]
The user facility reported that a patient sustained a second degree burn during a tympanomastoidectomy procedure in which the opmi pentero microscope was used. The burn was located on the antihelix of the operated ear. The burn was seen after surgery, at the first clinic visit on post-operative day 5. A topical antibiotic treatment (bacitracin) was administered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2017-00015 |
| MDR Report Key | 7102956 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-12-10 |
| Date of Report | 2017-11-10 |
| Date of Event | 2015-11-03 |
| Date Mfgr Received | 2017-11-10 |
| Device Manufacturer Date | 2007-12-18 |
| Date Added to Maude | 2017-12-10 |
| 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 | RISK MANAGER |
| 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 |
| Generic Name | MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | FSO |
| Date Received | 2017-12-10 |
| Model Number | NA |
| Catalog Number | 302582-9901-000 |
| 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. Other | 2017-12-10 |