MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROBE SAPHYRE 90DEG; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	7209686
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during cleaning, the probe was hot given that the controller error was not displayed.There was a back-up device available to complete the procedure, with neither significant delay nor patient/user injuries.
Additional Manufacturer Narrative
An evaluation was performed by the smith and nephew and could confirm the customer complaint for the probe was hot but a controller error was not displayed.A visual inspection was performed and showed the probe to have severe melting of the insulation at the tip and the electrode is worn.This damage is caused by excessive use and would cause the probe to become hot.No manufacturing related defects were observed.

• Brand Name: PROBE SAPHYRE 90DEG
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 8200102
• Report Number: 3003604053-2018-00197
• Device Sequence Number: 223190
• Product Code: GEI
• UDI-Device Identifier: 03596010470560
• UDI-Public: 03596010470560
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K991218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 7209686
• Device Lot Number: 1197780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Received by Manufacturer: 12/20/2018
• Supplement Date Received by Manufacturer: 03/01/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 03/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1