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 2017-11-21 for OPMI PENTERO 302582-9901-000 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[92712508]
During investigation of this event, the health care professional (hcp) indicated that the light intensity start value for the microscope was set to 76%. The hcp further stated that the patient's skin was exposed to the xenon light for 1 hour, 20 minutes at a focal distance of 250 mm. High light intensity supports a burn of surrounding tissue, especially if a short focal distance is used for a long duration. The user manual (g-30-1458-en, issue 9. 1, pages 22-24) discusses in detail the different factors that can influence the risk of burns and recommends measures to prevent them. - (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[92712509]
The health care professional (hcp) reported that a patient sustained a third degree burn during a tympanomastoidectomy procedure in which an opmi pentero microscope was used. The 2. 0 x 2. 5 cm burn was located on the back of the ear above the surgical area. The burn was recognized intraoperatively and required excision and repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2017-00013 |
| MDR Report Key | 7051109 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-21 |
| Date of Report | 2017-10-24 |
| Date of Event | 2017-10-24 |
| Date Mfgr Received | 2017-10-24 |
| Device Manufacturer Date | 2007-12-18 |
| Date Added to Maude | 2017-11-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| 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 | EPT |
| Date Received | 2017-11-21 |
| 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 | 0 |
| Device Event Key | 0 |
| Manufacturer | CARL ZEISS MEDITEC AG (OBERKOCHEN) |
| Manufacturer Address | RUDOLF-EBER-STRASSE 11 OBERKOCHEN, BADEN-WUERTTEMBERG 73447 GM 73447 |
| Brand Name | OPMI PENTERO |
| Generic Name | MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | FSO |
| Date Received | 2017-11-21 |
| 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. Congenital Not Applicablenomaly; 2. Required No Informationntervention | 2017-11-21 |