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 |