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 2017-05-05 for OPMI PICO ON S100 FLOOR STAND 000000-1095-102 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[74656747]
A zeiss field service engineer (fse) performed an on-site inspection and found that the screw mechanism that holds the optical head of the microscope safely to the stand was missing. The fse re-secured the optical head onto the stand with the screw mechanism and put the microscope back into service. The manufacturer concluded that the root cause of the optical head falling the second time is due to user error. Immediately after receiving the first report of the optical head falling on (b)(6) 2017, the doctor was advised by the local zeiss distributor not to use the system until the device is repaired by zeiss service, which was planned for and performed on (b)(6) 2017. However, the doctor decided to re-mount the optical head of the microscope onto the stand and proceeded to use the device again before it could be repaired. The user manual (g-30-1781-en, version 7. 1, 2016-03-09, page 10 and 11) states "the correct use of the device is absolutely vital for safe operation. Therefore, please thoroughly familiarize yourself with the content of these instructions for use before starting up the system". "modifications and repairs on this device or any equipment operated together with this device may only be performed by zeiss service. " the user manual (g-30-1781-en, version 7. 1, 2016-03-09, page 15, 208) further advises that "if a failure occurs which you cannot correct with the aid of the chapter 'what to do in the event of malfunctions', attach a sign to the device stating it is out of order and contact our service representative. "
Patient Sequence No: 1, Text Type: N, H10
[74656748]
The healthcare professional (hcp) reported that on (b)(6) 2017, during a procedure the optical head of the opmi pico on a s100 floor stand became completely loose. The doctor was able to catch the falling head preventing it from hitting the floor or any person. The doctor mounted the optical head back onto the stand and completed the procedure successfully with the same microscope. No one was injured due to this incident. The hcp reported the same problem of the falling optical head the previous day to the local zeiss distributor and was advised not to use the system until it is repaired, which was planned for and performed on (b)(6) 2017. That incident is reported under mdr #9615010-2017-00005.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2017-00006 |
| MDR Report Key | 6549515 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-05-05 |
| Date of Report | 2017-05-05 |
| Date of Event | 2017-04-05 |
| Date Mfgr Received | 2017-04-05 |
| Device Manufacturer Date | 2016-09-26 |
| Date Added to Maude | 2017-05-05 |
| 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 PICO ON S100 FLOOR STAND |
| Generic Name | SURGICAL MICROSCOPE |
| Product Code | FSO |
| Date Received | 2017-05-05 |
| Model Number | NA |
| Catalog Number | 000000-1095-102 |
| 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 | 2017-05-05 |