MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-19 for HPC-3 HUBREGTSE TRIPLE LUMEN NEEDLE KNIFE G24885 manufactured by Wilson-cook Medical, Inc..
[180707100]
Physician was using hpc-3 huibregtse triple lumen needle knife during a procedure. The needle knife dropped off and fell into the pt. Physician visualized it and was able to remove it using forceps through the egd scope. No pt injury or extra procedure or recovery time needed. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093151 |
| MDR Report Key | 9734016 |
| Date Received | 2020-02-19 |
| Date of Report | 2020-02-17 |
| Date of Event | 2019-12-31 |
| Date Added to Maude | 2020-02-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | HPC-3 HUBREGTSE TRIPLE LUMEN NEEDLE KNIFE |
| Generic Name | ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY |
| Product Code | ODD |
| Date Received | 2020-02-19 |
| Model Number | G24885 |
| Catalog Number | HPC-3 |
| Lot Number | W4205339 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WILSON-COOK MEDICAL, INC. |
| Manufacturer Address | WINSTON-SALEM NC 27105 US 27105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-19 |