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 2016-08-08 for OPMI PICO ON S100 WALL MOUNT 000000-1403-570 manufactured by Carl Zeiss Meditec Ag (oberkochen).
[51501027]
A zeiss field service engineer (fse) performed an on-site inspection and found that the wall mount plate, on which the opmi pico s100 wall mount microscope system was mounted, came loose and caused both components, the wall mount plate and opmi pico microscope system, dropping on the floor. The fse did not find a problem with the zeiss related opmi pico s100 wall mount microscope installation onto the wall mount plate. The hcp reported that the installation of the wall mount plate was not done properly and wrong hardware (drywall screws) was used to secure the wall mount plate to the wall structure. The wall mount plate used was not a zeiss provided wall mount plate. Zeiss records confirm that the installation of the wall mount plate for preparing the wall structure was done prior to the opmi pico microscope system installation and it was confirmed to be done in accordance to the previously provided specifications defined in the zeiss planning manual. The planning manual, (b)(4), version 8. 2, (b)(6) 2014, defines the requirements for a safe mounting of the opmi pico s100 wall mount microscope system and guides the customer how to prepare the wall structure. The manual contains a complete section with "customer's preparatory responsibilities" in order ensure a safe wall structure preparation by the customer. The document advises on page 82 about the wall mount installation including a warning sign the wall mount must only be installed on the original wall flange or, if necessary, on the original wall plate from carl zeiss. "
Patient Sequence No: 1, Text Type: N, H10
[51501028]
The healthcare professional (hcp) reported that the supporting wall mount plate, on which the opmi pico with s100 wall mount microscope system was mounted, came loose from the wall and the wall mount plate and the whole opmi pico microscope dropped on the floor. At the time of the incident, no one used the microsope and no patient was involved. There was no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615010-2016-00013 |
| MDR Report Key | 5855301 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-08-08 |
| Date of Report | 2016-08-06 |
| Date of Event | 2016-04-01 |
| Date Mfgr Received | 2016-07-20 |
| Device Manufacturer Date | 2010-10-22 |
| Date Added to Maude | 2016-08-08 |
| 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 WALL MOUNT |
| Generic Name | MICROSCOPE, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | FSO |
| Date Received | 2016-08-08 |
| Model Number | NA |
| Catalog Number | 000000-1403-570 |
| 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 | 2016-08-08 |