MAUDE Adverse Event Report: ANGIODYNAMICS UNIBLATE ELECTRODE; ELECTROSURGICAL PROBE,

Catalog Number	H7877001035981
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation.(b)(4).
Event or Problem Description
As reported to angiodynamics on november 28, 2017: this medwatch is not to report a device malfunction, but to report an adverse patient effect.Patient was having rfa to treat osteoid osteoma in the left distal femur.The burn was at the insertion site.The doctor and clinical specialist both agree that this occurrence was a result of the placement of the cannula introducer location, causing a "backfire" of heat to burn the tissue due to the superficial location, not as a result of a malfunction of the device.It was reported that the disposable device was discarded by the user and is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of a patient experiencing a burn is confirmed based on the description although no sample or photographic evidence was provided.Although the complaint description of a patient burn is confirmed, a definitive root cause for the event cannot be determined.A possible contributing factor could be if the rf power was activated prior to the target tissue being reached.Although no sample was returned and a root cause cannot be definitively determined, this does not appear to be a result of any manufacturing anomalies.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.The instructions for use, which is supplied to the user with this catalog number, contains the following statements: "do not attach anything (i.E., clamps, etc.) to the device.This may damage the insulation, which could contribute to patient injury.Patients with peripheral vascular deficiency are at increased risk of thermal injury from dispersive electrodes.If the device is being used in a laparoscopic procedure, activation of the device when not in contact with target tissue may cause capacitive coupling.Having rf power on at the same time as infusion using a method different from these instructions may alter the path of the electrical energy away from target tissues.Using imaging guidance (e.G., ultrasound, ct) place the device into the target tissue.The tip of the trocar should be placed at the distal edge of the lesion.Using the 1-cm markings on the trocar can assist in placement of the device." 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 reference # (b)(4).

• Brand Name: UNIBLATE ELECTRODE
• Common Device Name: ELECTROSURGICAL PROBE,
• Manufacturer (Section D): ANGIODYNAMICS; one horizon way; manchester GA 31816
• MDR Report Key: 7133260
• Report Number: 1056436-2017-00132
• Device Sequence Number: 1211122
• Product Code: GEI
• UDI-Device Identifier: H7877001035981
• UDI-Public: H7877001035981
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K010060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: H7877001035981
• Device Lot Number: 5226046
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2017
• Supplement Date Received by Manufacturer: 11/29/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention