MAUDE Adverse Event Report: MEDLINE RENEWAL REPROCESSED ABLATION ELECTRODE; ELECTROSURGICAL ACCESSORY

Model Number	AC 4045-01
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question was returned for evaluation, and we confirmed that the device had been reprocessed.The reported issue was confirmed.A review of the device history record confirmed that all validated parameters were met and all required inspections were performed.This is the first report of this type of failure for this device; therefore, we will continue to monitor trends.Unfortunately, we do not have enough information at this time to determine the root cause of the failure.However, if additional information surrounding the incident is received then this report will be updated.The user reported a 20-30 minute delay during the procedure but there was no patient consequence or subsequent injury.Therefore in an abundance of caution, we are filing this medwatch report.
Event or Problem Description
We received a report indicating that the tip of a reprocessed ablation wand detached during use.The tip was detected via x-ray and was removed at the time of the procedure.

• Brand Name: REPROCESSED ABLATION ELECTRODE
• Common Device Name: ELECTROSURGICAL ACCESSORY
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• MDR Report Key: 6354018
• Report Number: 3032391-2017-00004
• Device Sequence Number: 682345
• Product Code: GEI
• UDI-Device Identifier: 10888277383562
• UDI-Public: 10888277383562
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K012669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/23/2017

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: 10/31/2019
• Device Model Number: AC 4045-01
• Device Lot Number: 324004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2017
• Initial Report FDA Received Date: 02/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention