MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-02 for PNEUMO-MATIC INSUFFLATION NEEDLE 900-200 manufactured by Cooper Surgical.
[99095156]
Cooper surgical, pneumo-matic insufflation needle was tested prior to the start of the procedure. It would not sense occlusion. Therefore we replaced it with a new one (with the same lot number) that then worked fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075061 |
| MDR Report Key | 7240998 |
| Date Received | 2018-02-02 |
| Date of Report | 2018-02-01 |
| Date of Event | 2018-02-01 |
| Date Added to Maude | 2018-02-05 |
| 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 | 0 |
| Brand Name | PNEUMO-MATIC INSUFFLATION NEEDLE |
| Generic Name | PNEUMOPERITONEUM NEEDLE |
| Product Code | FHO |
| Date Received | 2018-02-02 |
| Model Number | 900-200 |
| Catalog Number | 900-200 |
| Lot Number | 225666 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL |
| Manufacturer Address | TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-02 |