MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED ELECTROSURGICAL ELECTRODE

Model Number	227301
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to medline renewal for evaluation.Upon receipt, medline renewal confirmed the device had been reprocessed.Further evaluation found that the device passed all functional and electrical tests; therefore the reported issue could not be confirmed at this time.Our investigation included a review of the device history record, and we reconfirmed that all processes were conducted as required, and that the device met inspection requirements prior to packaging and release.The specific cause of the failure could not be determined.Although no patient harm was reported, a delay in the procedure was reported due to obtaining a new device; therefore medline renewal is filing this medwatch report in an abundance of caution.(b)(4).
Event or Problem Description
Medline renewal received a report indicating a reprocessed depuy mitek vapr side effect electrode, w/integrated hand piece, model 227301, was not recognized by the generator when it was plugged in during a surgical procedure.Therefore the device could not be used.The report did not indicate that the device failure resulted in any patient harm.Another device was readily available to complete the procedure; therefore no patient harm or additional medical intervention was reported as a result of the incident.

• Brand Name: MEDLINE RENEWAL REPROCESSED ELECTROSURGICAL ELECTRODE
• Common Device Name: ELECTROSURGICAL ELECTRODE
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• MDR Report Key: 6088216
• Report Number: 3032391-2016-00039
• Device Sequence Number: 758339
• Product Code: GEI
• UDI-Device Identifier: 10888277379855
• UDI-Public: 10888277379855
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 11/08/2016

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: Physician
• Device Expiration Date: 09/30/2019
• Device Model Number: 227301
• Device Lot Number: 316408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2016
• Initial Report FDA Received Date: 11/08/2016
• 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