MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-19 for YELLOWFIN STIRRUP O-YFASI manufactured by Allen Medical Systems, Inc..
[136462537]
While placing robotic ports, right stirrup hinge broke and fell to the ground while the patient was in full trendelenberg position. Surgical tech picked up patient's leg as soon as possible and attending surgeon was notified. Right stirrup was replaced. Evaluation of the device showed that one of the pins that engages the locking mechanism was missing and the other pin was backed out of the hole enough to disengage, causing the leg holder to fall. No patient injury was noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8349403 |
| MDR Report Key | 8349403 |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-13 |
| Date of Event | 2018-12-20 |
| Report Date | 2019-02-13 |
| Date Reported to FDA | 2019-02-13 |
| Date Reported to Mfgr | 2019-02-19 |
| Date Added to Maude | 2019-02-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | YELLOWFIN STIRRUP |
| Generic Name | SUPPORT, PATIENT POSITION |
| Product Code | CCX |
| Date Received | 2019-02-19 |
| Catalog Number | O-YFASI |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 100 DISCOVERY WAY ACTON MA 01720 US 01720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-19 |