MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROBE SAPHYRE 60 DEG 3MM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	7209685
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a hip labial repair surgery it was found that the handle of the probe was overheated and scalding, as well as slight smoke/steam was observed.Finally, a backup device was used to complete the surgery.
Additional Manufacturer Narrative
An evaluation was performed by smith & nephew and could confirm the customer complaint for the probe overheating.A visual inspection was performed and showed the probe has been used in the field.The insulation on the side of the electrode is peeled back.This would cause fluid to enter the probe and cause it to overheat.The insulation is peeled due to contact with another source.No manufacturing related defects were observed.

• Brand Name: PROBE SAPHYRE 60 DEG 3MM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 7153752
• Report Number: 3003604053-2017-00345
• Device Sequence Number: 832572
• Product Code: GEI
• UDI-Device Identifier: 03596010470287
• UDI-Public: (01)03596010470287(17)200331(10)1186143
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2018

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: 03/31/2020
• Device Model Number: 7209685
• Device Catalogue Number: 7209685
• Device Lot Number: 1186143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 12/29/2017
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 48