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 2016-08-02 for OPMI PICO ON S100 FLOOR STAND 000000-1095-102 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[51004062]
Narrative: zeiss records indicate that there is no service contract or service history for the microscope in question. The hcp confirmed that the last service was done more than 7 years ago. A field service engineer performed an on-site inspection of the microscope and found that the pneumatic spring was leaking and did not hold position. The user manual g-30-1385-en, issue 5. 0, printed on 14. 05. 2001, advises on several pages to contact service, if a function of the microscope fails, e. G. Page 16, 38, 42. The user manual informs about a regular maintenance interval of every 24 months for the suspension system. The manufacturer's conclusion is that normal use and normal maintenance and repair following zeiss procedures could not lead to the occurred scope arm drop. The user manual advises on page 103 to perform a detailed function check before surgery and without patient present. This contains under title "setting the suspension arm weight compensation" also the proper balancing of the microscope.
Patient Sequence No: 1, Text Type: N, H10
[51004063]
The healthcare professional (hcp) reported the opmi pico microscope arm was in the upper standby position when dropping suddenly about two feet. The scope head hit the patient above the left eyebrow. The hcp described the resulting abrasion as "superficial" and confirmed that no medical intervention was needed. The scope was used for routine examination of patient's ears. The examination was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2016-00012 |
| MDR Report Key | 5842182 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-08-02 |
| Date of Report | 2016-08-02 |
| Date of Event | 2016-06-23 |
| Date Mfgr Received | 2016-07-06 |
| Device Manufacturer Date | 2002-07-03 |
| Date Added to Maude | 2016-08-02 |
| 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 | RP |
| 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 |
| Product Code | FSO |
| Date Received | 2016-08-02 |
| 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 | 1. Other | 2016-08-02 |