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

Catalog Number	7210113
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the surgery when the wand was used for soft tissue ablation, there was an arc at the return electrode it emitted red light.There was a 5 min delay.A backup device was available, no patient injury reported.
Additional Manufacturer Narrative
The device, which was used in a procedure, was returned for evaluation.The evaluation was performed by smith and nephew and could not confirm the customer complaint for the return electrode emitted red light.A visual inspection was performed and showed the probe has been used in the field.There is insulation damage at the tip and around the return electrode.This damage is caused by contact with another source.Functional inspection was performed.The probe was connected to the generator and all appropriate setting were displayed.The probe was activated in saline solution and functioned as intended.Possible root cause for a red light to display from the return electrode would be if the probe was buried in the soft tissue completely covering the active electrode.A device history record review was performed and showed no non-conformance or deviations associated with the lot number provided.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.No manufacturing related defects were observed.

• Brand Name: PROBE SAPHYRE II 60DEG 3MM SUCTION
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• MDR Report Key: 9126230
• Report Number: 3003604053-2019-00124
• Device Sequence Number: 11346087
• Product Code: GEI
• UDI-Device Identifier: 03596010483287
• UDI-Public: 03596010483287
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/07/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/06/2021
• Device Catalogue Number: 7210113
• Device Lot Number: 2022658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 09/03/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1