MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-18 for ULTRA PLUME AWAY 6.0 0620-030-606 manufactured by Cooper Surgical, Inc..
[131168585]
Cooper surgical inc. , ultra plume away 6. 0 was received in the sterile packaging with the suction tubing bent over the tubing connector to the point where the memory of the tubing could not be corrected, and the device could not be utilized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082278 |
| MDR Report Key | 8180620 |
| Date Received | 2018-12-18 |
| Date of Report | 2018-12-17 |
| Date of Event | 2018-12-17 |
| Date Added to Maude | 2018-12-19 |
| 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 | ULTRA PLUME AWAY 6.0 |
| Generic Name | LAPAROSCOPIC SMOKE EVACUATOR |
| Product Code | FCZ |
| Date Received | 2018-12-18 |
| Model Number | 0620-030-606 |
| Catalog Number | 0620-030-606 |
| Lot Number | 256710 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-18 |