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 2017-06-22 for OPMI PENTERO 000000-0480-801 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[78226751]
Patient Sequence No: 1, Text Type: N, H10
[78226752]
The health care professional (hcp) reported that a patient had a third degree burn on the left wrist immediately after a radiocephalic arteriovenous fistula creation procedure using an opmi pentero microscope. The burn was 5cm x 3. 5 cm around the surgical area and included the surgical area. Wound care was administered. Subsequent consult to plastic surgery has required an additional surgical procedure for excisional debridement and full thickness skin graft. All pertinent information available to carl zeiss meditec has been submitted in this report.
Patient Sequence No: 1, Text Type: D, B5
[86570166]
A field service engineer (fse) performed an on-site inspection of the microscope and its light function. No failure was detected that could lead to the reported injury. The actual light intensity settings used during the surgery could not be determined as the microscope had been accessed prior to the fse's inspection. The manufacturer's investigation of the device log showed no error during system use. The site reported a small working distance of 12-14 inches from the skin of an adolescent patient. The site also reported that the area around the incision was not protected by an incision drape during the 50-60 minutes of light exposure. The site further reported that the health care professional was not trained to use the microscope and was not aware of the relevance of careful light settings. The user manual (g-30-1458-en, issue 6. 1) explains in detail the numerous factors that can influence the risk of burns, including but not limited to, light intensity, working distance, size of illuminated field, duration of exposure, and patient skin type. Description of further updates: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615010-2017-00007 |
| MDR Report Key | 6662481 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-22 |
| Date of Report | 2017-09-07 |
| Date of Event | 2017-05-22 |
| Date Mfgr Received | 2017-05-23 |
| Date Added to Maude | 2017-06-22 |
| 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 |
| 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 |
| Remedial Action | IN |
| 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 | EPT |
| Date Received | 2017-06-22 |
| Model Number | NA |
| Catalog Number | 000000-0480-801 |
| 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 | 2017-06-22 |
| Model Number | NA |
| Catalog Number | 000000-0480-801 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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. Required No Informationntervention | 2017-06-22 |