MAUDE Adverse Event Report: MEDLINE RENEWAL MEDLINE RENEWAL REPROCESSED ENT ABLATION WAND; ELECTROSURGICAL ELECTRODE, COBLATOR

Model Number	EIC 5872-01
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device in question was returned to medline renewal for evaluation.We confirmed that the device was a reprocessed arthrocare coblator ii, ent evac 70 xtra plasma wand, w/integrated saline line and integrated cable, model eica 5872-01.The device was used and had not been decontaminated at the time of evaluation.The device was microscopically inspected.The tip contained patient and procedure debris, and the electrodes showed signs of significant wear.An attempt was made to recreate the "smoke" that was observed by the user, but medline renewal was unable to duplicate the observation.Our investigation also included a review of the device history record, and we reconfirmed that all processes were conducted as required, and that the device met all the inspection requirements prior to packaging and release.Medline renewal performed a retrospective review of complaints and determined that this incident met the criteria for mdr reporting but was not filed within the required 30 day timeframe.Although no patient harm was reported, due to the minimal detail provided and the intervention that was reported, medline renewal is retrospectively filing this medwatch report in an abundance of caution.This medwatch report was originally submitted on 09/27/2016, however due to an internal error, this report was submitted through the esg test account instead of the esg production account.Consequently, cdrh did not receive this report.Therefore, this medwatch report now reflects today's date which corresponds with the file transmission through the esg production account.
Event or Problem Description
Medline renewal received a report that a reprocessed ent ablation wand was smoking during use.The user was required to replace the device for a new one in order to complete the case.

• Brand Name: MEDLINE RENEWAL REPROCESSED ENT ABLATION WAND
• Common Device Name: ELECTROSURGICAL ELECTRODE, COBLATOR
• Manufacturer (Section D): MEDLINE RENEWAL; 2747 sw 6th st.; redmond OR 97756
• MDR Report Key: 6088138
• Report Number: 3032391-2016-00017
• Device Sequence Number: 10956284
• Product Code: GEI
• UDI-Device Identifier: 10888277382640
• UDI-Public: 10888277382640
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K100543
• 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: 10/31/2018
• Device Model Number: EIC 5872-01
• Device Catalogue Number: EIC 5872-01
• Device Lot Number: 261967
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2016
• 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