MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-06-24 for OPMI PENTERO 302582-9901-000 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[48092246]
Narrative: a field service engineer (fse) inspected the instrument, including light setting functions, and confirmed that the instrument operates within manufacturer specifications. The user manual explains in detail the risk of burns caused by high illumination intensity. The user manual instructs the user to set the illumination intensity to the minimum value required with 25% recommended as a starting value. A visual warning can be displayed when an illumination threshold value is exceeded. The default factory threshold is set to be active with a value of 25%. The user manual also describes the contribution of focal distance, time and patient skin type to burns. Finally the user manual discusses the susceptibility of skin around the incision to burns with a recommendation to use wet gauze in the area to reduce the chance of burns. The healthcare professional admitted that this could have been an user error after having been advised by the fse about how to work safely with the scope light.
Patient Sequence No: 1, Text Type: N, H10
[48092247]
This is case six of six reported cases of orl surgery (oto-rhino-laryngology) having occurred in 2014 and 2015 involving the same customer site in (b)(6) and the same microscope. The manufacturer received information from the healthcare professional that the patient suffered a skin burn after surgery. . In this case, the surgery started with 20% of the light intensity and the surgical area was well focused. At the end of the surgery, the healthcare professional noted a skin burn aside the front part of the ear. The customer also discovered that the light intensity was at 100% at the end of the surgery no further information regarding patient or event could be obtained, e. G. About severity of the skin burn or potential follow-up treatment for patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2016-00010 |
| MDR Report Key | 5747237 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-06-24 |
| Date of Report | 2016-06-23 |
| Date of Event | 2015-11-06 |
| Date Mfgr Received | 2016-05-25 |
| Device Manufacturer Date | 2013-03-28 |
| Date Added to Maude | 2016-06-24 |
| 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 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPMI PENTERO |
| Generic Name | MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | FSO |
| Date Received | 2016-06-24 |
| 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 | 2016-06-24 |