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	05/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility / importer report number: mw5078150.
Event or Problem Description
It was reported that there was metal shavings coming from the instrument.Procedure was completed with a backup device with no patient injury 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.However, if the product is returned in the future the complaint can be reopened and evaluated.Our quality department will continue to monitor for trends.

• 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: 7752313
• Report Number: 3003604053-2018-00123
• Device Sequence Number: 19336011
• Product Code: GEI
• UDI-Device Identifier: 03596010492302
• UDI-Public: (01)03596010492302(17)210331(10)4031963
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K012314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2018

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: 03/31/2021
• Device Model Number: 7209855
• Device Catalogue Number: 7209855
• Device Lot Number: 4031963
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 08/06/2018
• Supplement Report FDA Received Date: 09/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1