MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PROBE,SAPHYRE II, 90DEG,3MM,SUCTION; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	7210111
Medical Device Problem Codes	Peeled/Delaminated (1454); Electrical Shorting (2926)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during a knee debridement procedure using saphyre probe, an electrical leakage occurred.The sheathing of the wand was peeling, and there was an electric shock feeling.The procedure was completed with non-significant surgical delay using a back-up device.No patient complications were reported.
Additional Manufacturer Narrative
H10, h3, h6: the reported device was received for evaluation.It was determined the device contributed to the reported event.A complaint history review found similar reported events.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A visual inspection found that the sheathing of the wand is peeling off exposing the wiring.Due to the condition of the returned device, functional testing could not be performed.The complaint of a peeled sheath was confirmed, and the root cause was associated with component failure.Factors that could have contributed to the reported event include an inadvertent impact inconsistent with normal use.The complaint of an electric shock was not confirmed, and the root cause cannot be determined due to condition device was received in.Factors that could have contributed to the reported event include damage to the insulation.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).

• Brand Name: PROBE,SAPHYRE II, 90DEG,3MM,SUCTION
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 150 minuteman road; andover MA 01810
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 14332568
• Report Number: 3003604053-2022-00016
• Device Sequence Number: 6209588
• Product Code: GEI
• UDI-Device Identifier: 03596010481498
• UDI-Public: 03596010481498
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K991218
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2024
• Device Model Number: 7210111
• Device Catalogue Number: 7210111
• Device Lot Number: 2067575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 06/21/2022; 10/30/2023
• Initial Report FDA Received Date: 05/08/2022
• Supplement Report FDA Received Date: 06/22/2022; 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Female