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 2017-02-13 for OPMI PICO ON S100 FLOORSTAND 000000-1080-324 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[67338897]
Patient Sequence No: 1, Text Type: N, H10
[67338898]
The healthcare professional (hcp) reported that during a myringotomy treatment on an infant, the arm of the microscope dropped suddenly downwards. The surgeon was able to deflect the opmi head away from the patient on the way down, why it did not make contact with the patient. The treatment could be completed.
Patient Sequence No: 1, Text Type: D, B5
[75533906]
A zeiss field service engineer (fse) performed an on-site inspection and found that the u-shaped bracket, that secures one end of the tilting scope arm's pneumatic spring, was bent outwards on both sides to the extent that the spring was no longer engaged. Without an engaged pneumatic spring, the s100 tilting arm and attached microscope head will drop downwards under the force of gravity. The microscope has been in service for more than 15 years without a similar problem. The exact cause of the bending of the u-shaped bracket is unknown as the customer declined to return the defective tilting arm back to the manufacturer for further investigation. The manufacturer's evaluation concluded that the system is designed so that there are no lateral forces that would contribute to the observed bending of the bracket. It is probable that the bracket was tampered with because, by design, it is not subject to lateral forces. The manufacturer's conclusion is that normal maintenance and repair following zeiss procedures could not lead to the observed bracket bending. The user manual (g-30-1385-en, issue 5. 0, printed on 14. 05. 2001, page 7) advises that modifications and repairs may only be performed by zeiss or by other authorized persons. It states also that zeiss does not accept any liability for damage caused by unauthorized persons.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615010-2017-00001 |
| MDR Report Key | 6327841 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-02-13 |
| Date of Report | 2017-05-05 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-02-01 |
| Device Manufacturer Date | 2001-04-09 |
| Date Added to Maude | 2017-02-13 |
| 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 |
| 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 PICO ON S100 FLOORSTAND |
| Generic Name | MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | FSO |
| Date Received | 2017-02-13 |
| Model Number | NA |
| Catalog Number | 000000-1080-324 |
| 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. Other | 2017-02-13 |