MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-12-17 for UNIVERSAL FLAT PANEL YOKE, NO CABLES, LANDSCAPE 0682400049 manufactured by Stryker Communications.
[1273476]
It was reported that within operating room #(b) (6), the monitor #1 yoke is missing the m3 screw. The issue was found prior to cases and no pts were present. No adverse consequences occurred as a result of this malfunction.
Patient Sequence No: 1, Text Type: D, B5
[8320068]
There is no established expiration date for the mentioned device. Device manufactured date is unk at this point. Further attempts will be made for this info. Evaluation summary - the said device was evaluated in the field. When the stryker engineers inspected the single flat panel suspension, they noticed that the m3 screw was missing on the safety segment for the monitor. This can potentially lead to an adverse event if several cascading events occur. The safety sleeve would have to slide up the collar of the suspension and then the safety clip would have to fall out. If this took place, the monitor could fall slightly, but the cables to the monitor would likely hold the monitor up. The cause of the m3 screw missing is unk at this point. Further investigation is ongoing. This is not a single-use device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031963-2009-00050 |
| MDR Report Key | 1566732 |
| Report Source | 00 |
| Date Received | 2009-12-17 |
| Date of Report | 2009-11-19 |
| Date of Event | 2009-11-19 |
| Date Mfgr Received | 2009-11-19 |
| Date Added to Maude | 2010-07-12 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KIM GRAUL |
| Manufacturer Street | 1410 LAKESIDE PKWY |
| Manufacturer City | FLOWER MOUND TX 75028 |
| Manufacturer Country | US |
| Manufacturer Postal | 75028 |
| Manufacturer Phone | 9724107100 |
| Manufacturer G1 | STRYKER COMMUNICATIONS |
| Manufacturer Street | 1410 LAKESIDE PKWY |
| Manufacturer City | FLOWER MOUND TX 75028 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75028 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL FLAT PANEL YOKE, NO CABLES, LANDSCAPE |
| Generic Name | YOKE |
| Product Code | LMD |
| Date Received | 2009-12-17 |
| Returned To Mfg | 2009-11-19 |
| Model Number | NA |
| Catalog Number | 0682400049 |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER COMMUNICATIONS |
| Manufacturer Address | FLOWER MOUND TX 75028 US 75028 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-17 |