MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-29 for YELLOWFINS * O-YFASI manufactured by Allen Medical Systems.
[3429160]
Throughout procedure patient was positioned in bilateral yellow fin stirrups with foot of bed removed. Upon completion of surgical procedure, the right yellow fin was squeezed in order to raise it to replace foot of bed. At this time, with the patient's leg still in the stirrup, the stirrup and stirrup holder fell off the bed. The handle of the stirrup hit the floor and the cst immediately grabbed the leg to avoid any rotation. With the help of the rn and crna, the cst was able to reapply the stirrup holder back on the bed, noting the tightening knob was very loose. The holder was securely reapplied and the stirrup was placed back in the holder. The patient's leg was carefully removed from the stirrup along with the left leg with no sign of trauma or deformity. Dr requested a portable right hip xray to be taken in pacu which was performed and the surgeon was notified of the incident and follow-up care. X-ray was negative. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3080037 |
| MDR Report Key | 3080037 |
| Date Received | 2013-03-29 |
| Date of Report | 2013-03-29 |
| Date of Event | 2013-03-11 |
| Report Date | 2013-03-29 |
| Date Reported to FDA | 2013-03-29 |
| Date Reported to Mfgr | 2013-04-26 |
| Date Added to Maude | 2013-04-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YELLOWFINS |
| Generic Name | STIRRUPS |
| Product Code | EYD |
| Date Received | 2013-03-29 |
| Model Number | * |
| Catalog Number | O-YFASI |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEN MEDICAL SYSTEMS |
| Manufacturer Address | 1 POST OFFICE SQUARE ACTON MA 01720394 US 01720 3948 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-29 |