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 2015-11-23 for OPMI PICO ON S100 FLOOR STAND S100 FLOORSTAND 000000-1403-542 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[31976910]
Narrative: this emdr was resubmitted on 2015-11-23 because the original emdr submission on 2015-08-11 did not receive the required three acknowledgements. A field service engineer(fse)performed an on-site inspection and found that the two bolts securing the xenon power supply illumination unit mounting plate to the s100 stand were broken. The microscope was repaired and put back into service. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[31976911]
The health care professional reported the following: while adjusting the opmi pico microscope on an s100 floor stand during a root canal surgery, the illumination module came loose from the suspension arm and began to fall. The assisting doctor caught the falling module before it hit the floor. The falling module did not enter the patient environment.
Patient Sequence No: 1, Text Type: D, B5
[58831858]
Manufacturer narrative: the broken parts were sent back to the manufacturer carl (b)(4). The material laboratory evaluated the break and concluded that the bolts broke due to a forced rupture, which typically occurs due to excessive force either impacting directly onto the bolts or indirectly by being applied to the illumination module and being transmitted to the bolts. Such a force could have impacted to the bolts a reasonable time prior to when the incident occurred. The exact cause why the bolts broke cannot be determined. Zeiss records indicate that the microscope in question has not been serviced by zeiss since the installation in 2013. The manufacturer reviewed the assembly process of the related module and confirmed that the assembly is controlled with a torque specification and the use of a calibrated tool. The inspection of the current lot of screws did not show any abnormality. The device history records do also not show any abnormalities. The risk of defective bolts and the potential of a falling system is considered in the risk analysis (ms-3rde-0062, v8, point 6. 8). The trend for this particular failure mode does not show any negative trend. The user manual (g_30_1781_v6_0_en_2013) instructs the user on page 12 to perform the following safety measures: " in order to prevent any impairment of the device's safety due to age, wear, etc. , the user must ensure that the device is subjected to the necessary safety checks" and on page 265 the following caution is stated: "risk of injury! Make sure that the regular technical safety checks required for this system in accordance with the applicable national regulations are performed on schedule and to the stipulated extent. ... The safety checks shall only be performed by the manufacturer or by qualified staff". (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[58831859]
Na
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2015-00010 |
| MDR Report Key | 5245208 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2015-11-23 |
| Date of Report | 2016-10-25 |
| Date of Event | 2015-06-16 |
| Date Mfgr Received | 2015-07-16 |
| Device Manufacturer Date | 2013-07-16 |
| Date Added to Maude | 2015-11-23 |
| 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 | 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 SURGERY |
| Product Code | FSO |
| Date Received | 2015-11-23 |
| Model Number | S100 FLOORSTAND |
| Catalog Number | 000000-1403-542 |
| Lot Number | NA |
| 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 | 2015-11-23 |