MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ELECTROBLADE RESECTOR,4.5 FULL RADIUS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	7209855
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that the surgeon was performing a sub acromial decompression using an electroblade and vulcan rf unit.Then he went to use the cautery feature and nothing happened.No error message.He checked the connections to the vulcan and all were plugged in correctly, he changed the electroblade and it did not cauterize as well.An error message appeared on the vulcan saying unable to determine voltage service required.There was no backup device available and no patient injury was reported.
Additional Manufacturer Narrative
Visual inspection and functional testing could not be performed because the device in question has not been returned for evaluation.Thus, the complaint could not be verified and a root cause could not be determined with confidence.It is difficult to perform an accurate evaluation of a failure without having the failed product to look at.As such the complaint is being closed without conclusion.

• Brand Name: ELECTROBLADE RESECTOR,4.5 FULL RADIUS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7355929
• Report Number: 3003604053-2018-00046
• Device Sequence Number: 113098
• Product Code: GEI
• UDI-Device Identifier: 03596010492302
• UDI-Public: (01)03596010492302(17)200930(10)3811572
• Combination Product (Y/N): N
• PMA/510(K) Number: K012314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2018

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: 09/18/2020
• Device Model Number: 7209855
• Device Catalogue Number: 7209855
• Device Lot Number: 3811572
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/20/2018
• Supplement Date Received by Manufacturer: 05/11/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 05/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1