MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-04-06 for NANOKNIFE SYSTEM 20300101 manufactured by Angiodynamics.
[105648342]
It was reported the customer performed an assessment on the reported nanoknife ire unit at their facility. The customer reported the event could not be duplicated and was functioning as intended when assessed. Therefore, it was determined by the customer not to return the unit to angiodynamics for assessment and repair. As angiodynamics did not perform a unit assessment, a root cause for the event cannot be determined. The customer's reported complaint description could not be confirmed since the unit was not returned for evaluation. Without receiving the unit for analysis, a root cause cannot be determined. It was noted that the unit seemed to be functioning properly after this event at the customer's facility. A potential root cause for this event may have been that the generator was working correctly but the display/monitor had malfunctioned. Disposable device review: the catalog and lot number of the disposable probe used during the event was not reported by the user. A ship history report (shr) was generated in order to ascertain the last three lots of all ire single electrode probes shipped to the reporting customer in the six months prior to the procedure date. This review indicated that the complainant had received lot numbers 5212396, 5212397 and 5188658. A review of the lot history records was performed for the packaging lots (5212396, 5212397 and 5188658) for catalog numbers 20400104 and 20400103 obtained through a ship history report for any deviations related to the reported defect of the complaint. The review confirms that the packaging lots and all component lots met all material, assembly, and performance specifications. A review of the device history records was performed for the reported nanoknife generator serial number (b)(4) for any deviations related to the reported defect of the complaint. The review confirmed that the unit met all material, assembly, and performance specification prior to distribution. The user manual, which is supplied to the user with this unit lists possible reasons for a high current message during the ablation delivery and the action to be taken by the user if the high current message is received: "possible reason: default voltage is set too high or inaccurate measurements entered. Action: abort delivery. Press the stop procedure button. Check that measurements were taken and entered correctly. Decrease the voltage setting. Repeat ablation delivery for any undelivered pulses. Possible reason: probes connected to wrong numbered generator output. Action: abort delivery. Press the stop procedure button. Verify probes are connected to the proper numbered output. Repeat ablation delivery for any undelivered pulses. Possible reason: probe exposures set too large. Action: abort delivery. Press stop procedure button. Decrease the probe exposure by 5mm. Repeat ablation delivery for any undelivered pulses. If applicable, perform subsequent pullback ablation to achieve desired ablation height. " the user manual also contains the statements: "use your clinical judgment to abort delivery if multiple over current conditions occur during pulse generation" and "at the completion of pulse generation when high current is detected, the user has two button options; continue procedure and stop procedure. Selecting the stop procedure button will reset the pulse generation screen, reduce the capacitors' charge to the test pulse voltage, and ready the device. Selecting the continue procedure button will display an action required pop-up screen, as shown in figure 5. 1. 47 (in the manual), with the following message: adjust voltages for high current segments". A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family. This type of complaint will continue to be monitored for trends. Complaint #(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[105648343]
As reported to angiodynamics on (b)(6) 2018: at the end of a (b)(4) case, the nanoknife unit displayed an intensity warning and then shut down. The display screen was black, but the generator continued delivering pulses (4 to 5 pulses). It was reported the patient experienced no harm or injury due to this event. After the incident, the generator was tested at the distributor technical service department (izasa) and the generator worked without incident. The distributor has determined not to return the unit for evaluation at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2018-00031 |
| MDR Report Key | 7402133 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-04-06 |
| Date of Report | 2018-04-03 |
| Date of Event | 2018-03-08 |
| Date Mfgr Received | 2018-03-08 |
| Date Added to Maude | 2018-04-06 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAW RYAN |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal | 12804 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NANOKNIFE SYSTEM |
| Generic Name | LOW ENERGY DIRECT CURRENT ABLATION SYSTEM |
| Product Code | OAB |
| Date Received | 2018-04-06 |
| Model Number | 20300101 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS |
| Manufacturer Address | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-06 |