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 2016-10-27 for OPMI PENTERO 900 302582-9902-000 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[58530377]
A zeiss field service engineer (fse) inspected the microscope onsite and replaced the opmi control board after his failure analysis. The manufacturer level 2 support engineer confirmed fse's finding and repair action after reviewing the error log of the microscope. The manufacturer evaluated the function deterioration of the microscope during surgery. The ir 800 function is described in the "indication for use" of the user manual as an accessory function. The essential functions with light, focus, zoom and brakes are still working in such a situation. The user manual g-30-1822-en version 2. 2 instructs the user on page 11 to "check the instrument for proper functionality or damage before each use. " and on page 359 to perform an ir800 function test prior to each surgery. The user manual recommends also on page 11 "... To take adequate precautions, depending on the application, to enable the surgical procedure or treatment to be finished without using this microscope... ". In this case, the opmi pentero 900 microscope was used without prior function test. The hcp decided to use a doppler system for monitoring the blood flow in the vessels, when the ir800 function of the opmi pentero 900 did not start. The hcp confirms that there are other factors not related to opmi pentero 900 malfunction, which can lead or contribute to the reported patient outcome of a paralysis ater an aneurysm emergency surgery.
Patient Sequence No: 1, Text Type: N, H10
[58530378]
The health care professional (hcp) reported that the opmi pentero 900 was used for an emergency aneurysm surgery due to a burst aneurysm. When trying to start the ir800 mode during surgery for monitoring the blood flow in the vessels, the ir800 function did not work. The hcp decided to use a doppler system (ultrasonic) instead and which was available in order to monitor the blood flow. The surgery was completed and no significant delay was reported. No other issues were reported. The hcp informed after surgery that the patient has a paralysis. No details about severity and body area were provided. The hcp stated that "the injury is not only a result of the malfunction of the opmi pentero 900, also other non-instrument related things play a role". There were no further details provided about patient outcome and the surgery during the follow-up with the doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2016-00016 |
| MDR Report Key | 6061191 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-27 |
| Date of Report | 2016-10-27 |
| Date of Event | 2016-09-25 |
| Date Mfgr Received | 2016-09-27 |
| Device Manufacturer Date | 2016-01-27 |
| Date Added to Maude | 2016-10-27 |
| 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 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPMI PENTERO 900 |
| Generic Name | MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | FSO |
| Date Received | 2016-10-27 |
| Model Number | 900 |
| Catalog Number | 302582-9902-000 |
| 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. Deathisabilit | 2016-10-27 |