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

Model Number	227204
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to for evaluation.We confirmed that the device had been reprocessed, and the reported issue was confirmed.Medline renewal was unable to confirm if the tip was retrieved from the patient.Our investigation included both an inspection of the returned device, and a review of the device history record (dhr).We reconfirmed that all processes were conducted as required, and that the device met inspection requirements prior to packaging and release.The root cause of the failure is unknown at this time, however if additional information is received then this report will be updated.There was no report of adverse patient consequence or medical intervention required as a result of the incident.However, in an abundance of caution, medline renewal is filing this medwatch report.
Event or Problem Description
We received a report indicating that the tip of a reprocessed ablation wand detached during use.It is unknown if the tip was successfully retrieved from the patient.Another device was readily available to complete the procedure.There was no report of patient harm and no information if medical intervention was required as a result of the incident.

• Brand Name: REPROCESSED ABLATION WAND
• Common Device Name: ABLATION WAND, ELECTROSURGICAL ACCESSORY
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• MDR Report Key: 6239668
• Report Number: 3032391-2017-00001
• Device Sequence Number: 914870
• Product Code: GEI
• UDI-Device Identifier: 10888277389502
• UDI-Public: 10888277389502
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/10/2017

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: 07/31/2019
• Device Model Number: 227204
• Device Lot Number: 311311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2016
• Initial Report FDA Received Date: 01/10/2017
• 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