MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-10 for NEUWAVE PR XT PROBE 20CM 15GA PR20XT manufactured by Neuwave Medical, Inc..
[182701674]
Product complaint # (b)(4). Attempts are being made to obtain the following information.? To date no response has been provided. If further details are received at a later date a supplemental medwatch will be sent. Can you please clarify when the probe tip broke off the device (after the procedure, during use in the case, in the patient, etc. )? If the probe tip broke during the procedure, was the tip removed from the patient? Did removal cause any changes to the patient care? Was there any patient consequence or change in the post-operative care of the patient as a result of the event? Attempts have been made to retrieve the device. To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent.
Patient Sequence No: 1, Text Type: N, H10
[182701675]
It was reported that the customer alerted the sales rep that they were getting repetitive "reflected power errors" on one of the two probes being used in a microwave ablation procedure. To mitigate, the sales rep recommended they make sure green portion of probe fully was embedded in tissue. Customer continued to get errors. Customer also mentioned that it appeared plastic sheathing was torn around distal cannula and tip appeared very charred. Customer reported the rp errors starting at about seven minutes into a ten minute cycle. Customer also noted temps reaching 170 c during cycle. Decision was made to discard probe and replace with a new probe. Final three minutes of cycle were completed without incident. The procedure was delayed by approximately ten minutes and was completed with no patient consequences reported. Upon examining the probe, the sales rep noticed that the distal 5 mm the tip of the probe was missing and alerted the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008769756-2020-00003 |
| MDR Report Key | 9687239 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-10 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-01-21 |
| Date Mfgr Received | 2020-03-06 |
| Date Added to Maude | 2020-02-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 3529 ANDERSON ST |
| Manufacturer City | MADISON 53704 |
| Manufacturer Country | US |
| Manufacturer Postal | 53704 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | NEUWAVE MEDICAL, INC. |
| Manufacturer Street | 3529 ANDERSON ST |
| Manufacturer City | MADISON 53704 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53704 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUWAVE PR XT PROBE 20CM 15GA |
| Generic Name | SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES |
| Product Code | NEY |
| Date Received | 2020-02-10 |
| Model Number | PR20XT |
| Catalog Number | PR20XT |
| Lot Number | ML19054346 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEUWAVE MEDICAL, INC. |
| Manufacturer Address | 3529 ANDERSON ST MADISON 53704 US 53704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-10 |