MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-07 for XPS XPS3000 manufactured by Medtronic Xomed, Inc..
[91224608]
Patient Sequence No: 1, Text Type: N, H10
[91224609]
During procedure, medtronic xomed debrider failed to perform. Trouble shot, by changing disposable components, and machines, and a second hand piece. Finally got the situation resolved by immediate use sterilization of the handpiece that was used earlier today, and machine changed out. Surgical time was spent waiting for the handpiece to be immediate use sterilized, approximately 15 minutes. During the trouble shooting time, this machine failed as well as the hand piece. We do not have the machine or hand-piece and therefore do not have identifying numbers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7005730 |
| MDR Report Key | 7005730 |
| Date Received | 2017-11-07 |
| Date of Report | 2017-10-19 |
| Date of Event | 2017-07-17 |
| Report Date | 2017-10-19 |
| Date Reported to FDA | 2017-10-19 |
| Date Reported to Mfgr | 2017-10-19 |
| Date Added to Maude | 2017-11-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | XPS |
| Generic Name | SYSTEM, SUCTION, LIPOPLASTY |
| Product Code | NLY |
| Date Received | 2017-11-07 |
| Model Number | XPS3000 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR. NORTH JAX FL 32216 US 32216 |
| Brand Name | XPS |
| Generic Name | SYSTEM, SUCTION, LIPOPLASTY |
| Product Code | MUU |
| Date Received | 2017-11-07 |
| Model Number | XPS3000 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR. NORTH JAX FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-07 |