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 2016-10-19 for OPMI PICO ON S100 FLOOR STAND 000000-1245-414 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[57872964]
Patient Sequence No: 1, Text Type: N, H10
[57872985]
The healthcare professional (hcp) reported that at the beginning of the dental procedure, the opmi pico microscope arm was being moved out from the parking positon to the planned working position. During this movement, the tension force holding the scope arm went suddenly away and the scope arm including the optical head were dropping downwards. The hcp was holding the optical head at this moment and he was able to retain the microscope. The microscope did not make contact with the patient. The treatment was completed successfully with another microscope in the other room. No injury occurred.
Patient Sequence No: 1, Text Type: D, B5
[68489706]
Narrative: a zeiss field service engineer (fse) performed an on-site inspection and found that the u-shape bracket was bent. This bracket holds the gas spring in the scope arm. In addition, the holding bolt of the gas spring head was missing. The fse replaced the entire scope arm and confirmed that the opmi pico scope is working per manufacturer specification. The manufacturer evaluated the defective scope arm with following result: due to the missing holding bolt on the gas spring head, lateral forces bent the u-shape bracket, where the holding bolt normally enters. The bending caused the gas spring slipping through the bracket, and then the scope arm dropped downwards as reported. The manufacturer's investigation concluded that the system is designed so that there are no lateral forces that would contribute to the observed bending of the bracket, when the holding bolt is inserted. The records indicate that the affected scope arm has not been serviced by zeiss. The customer confirmed that the scope was serviced by their internal technical department. The likely root cause is an improper service. 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. Further updates based on mfr evaluation: field b4: entered actual date for this mdr follow-up. Field g7: updated from "initial" to "follow-up # 1". Field h2: entered "device evaluation". Field h6 method code(s): updated from "10" to "10 - 38 - 3316". Field h6 result code(s): updated from "3233" to "115". Field h6 conclusion code(s): updated from "11" to "14 - 61". Field h7: added "repair". Field h10: added manufacturer narrative and description of additional information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615010-2016-00015 |
| MDR Report Key | 6041392 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-19 |
| Date of Report | 2017-02-13 |
| Date of Event | 2016-09-22 |
| Date Mfgr Received | 2016-09-22 |
| Device Manufacturer Date | 2002-11-01 |
| Date Added to Maude | 2016-10-19 |
| 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 FLOOR STAND |
| Generic Name | MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | FSO |
| Date Received | 2016-10-19 |
| Model Number | NA |
| Catalog Number | 000000-1245-414 |
| 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 | 2016-10-19 |