MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-02 for ALLY UTERINE POSITIONING SYSTEM UTERINE DELINEATOR ALLY UPS manufactured by Coopersurgical, Inc..
[182215046]
Uterine delineator machine was unlocked to move the arm, the mechanism stuck and when release the uterine delineator moved unexpectedly and the unit perforated the bladder. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093491 |
| MDR Report Key | 9780160 |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-28 |
| Date of Event | 2020-02-26 |
| Date Added to Maude | 2020-03-03 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLY UTERINE POSITIONING SYSTEM UTERINE DELINEATOR |
| Generic Name | CANNULA, MANIPULATOR / INJECTOR, UTERINE |
| Product Code | LKF |
| Date Received | 2020-03-02 |
| Model Number | ALLY UPS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-02 |