MAUDE Adverse Event Report: ANGIODYNAMICS 1500X RF GENERATOR; 1500X RADIO FREQUENCY GENERATOR

Model Number 700101731M

Device Problems Communication or Transmission Problem (2896); Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

The rfa unit has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

An angiodynamics employee reported an issue with this 1500x rfa generator.The following was reported: after placing the needle into the kidney and pressing on the generator, the generator displayed a message stating that the thermopad was not connected.After double checking the connections and taking out and then reconnecting, the machine asked for another purge; however, in order to do so, the needle has to be outside of the body.The radiologist was not prepared to take the needle out as he believed there would be a large bleed, so the needle was disconnected but left in-situ and another needle was opened.After purging the new needle, and placing alongside the original needle, a similar issue with connections occurred with a new thermopad.The generator did not display the same "no connection" message, but said it was poor and only one temperature reading came up on the generator.Ultimately, the procedure was aborted due to this event.It was indicated the reported rfa generator is available for return to the manufacturer for a device evaluation.This event meets the criteria a reportable adverse event; patient safety risk as treatment was not provided, but patient had been sedated.

Manufacturer Narrative

Serial number of unit correction.Reference (b)(4).

Manufacturer Narrative

Returned for evaluation was a rita 1500x rfa unit, sn (b)(6).Evaluation of the unit determined the rf pca was faulty and required replacement.The part is currently in transit from the supplier and once received, the unit will be repaired and tested per procedure; the reported complaint description was confirmed during the evaluation of the unit.The root cause for the reported failure/event was a faulty rf pca.The root cause of the faulty rf pca was not determined.A review of the device history records (service order system) was performed for the reported serial number (b)(6) 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.Labeling review: the user manual (rita 1500x user's guide and service manual), which is supplied to the user with this unit contains the following trouble shooting statements: "the 1500x rf generator requires no preventative maintenance, calibration, or testing prior to use.Once the generator is turned on the software runs through a self-test verifying the functionality of the generator.If the generator fails the self-test, call customer service at angiodynamics, inc." 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.Reference (b)(4).

• Brand Name: 1500X RF GENERATOR
• Type of Device: 1500X RADIO FREQUENCY GENERATOR
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• MDR Report Key: 11797481
• MDR Text Key: 249707585
• Report Number: 1319211-2021-00038
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: H787700101731M0
• UDI-Public: H787700101731M0
• Combination Product (y/n): N
• PMA/PMN Number: K040989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 700101731M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/10/2021
• Supplement Dates Manufacturer Received: 04/28/2021; 04/28/2021
• Supplement Dates FDA Received: 07/12/2021; 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1