MAUDE Adverse Event Report: CONMED CORPORATION ULTRABLATOR 90 DEGREE, 110MM LENGTH, 3.2MM DIAMETER

Model Number	ESA-5396
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices were returned to conmed for evaluation.Both probes appear to exhibited insulation dielectric failure due to reduced insulation thickness which is most likely caused by contact being made with another device.The manufacturing documents from the device history record have ben reviewed with special attention to the manufacturing and inspection of this product.The products released for distribution were found to have met all specifications prior to shipment.This is the only complaint against this lot of 95 devices.A two-year historical complaint review revealed 6 similar complaints involving 10 other devices.The failure occurrence rate for this device and failure mode, should all complaints have been confirmed, would be 0.0006.In that same timeframe, (b)(4) units have been manufactured and sold worldwide.A risk analysis was performed and deemed this failure as acceptable.Per the ifu for this device, the user is advised: - only use the device in conductive fluid to avoid damage to the insulation - to avoid contact with sharp and metal instruments at all times this incident type will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
It was reported that during an arthroscopic shoulder joint surgery, holes were observed on two esa-5396 ultrablator probes at the tip of the shaft.Therefore, the surgeon used an alternative one to complete the surgery.This report is raised on the basis of a reported device malfunction with potential for injury with recurrence.

• Brand Name: ULTRABLATOR 90 DEGREE, 110MM LENGTH, 3.2MM DIAMETER
• Common Device Name: ABLATOR
• Manufacturer (Section D): CONMED CORPORATION; 11311 concept blvd; largo FL 33773
• MDR Report Key: 7317160
• Report Number: 1017294-2018-00030
• Device Sequence Number: 119329
• Product Code: GEI
• UDI-Device Identifier: 10845854020623
• UDI-Public: (01)10845854020623(17)211023(30)1(10)786243
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2021
• Device Model Number: ESA-5396
• Device Catalogue Number: ESA-5396
• Device Lot Number: 786243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 03/06/2018
• Patient Sequence Number: 1