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

Model Number	7210111
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that during an arthroscopic shoulder surgery, the saphyre probe had an electrical leakage, there were sparks.The procedure was completed with a s+n back up device.There was no surgical delay and no further complications were reported.
Additional Manufacturer Narrative
H10: h3, h6: the reported device was not received for evaluation.However, another device was received.A visual inspection revealed no manufacturing abnormalities.The electrode shows no wear or damage.The shaft has minor physical markings but no burn marks or arc damage.Product was out of the original packaging.No packaging returned.The cable of the device has been cut off.The suction line is still present.A functional evaluation could not be performed due to the cut cable.An analysis of the customer provided images found what appears to be the tip of the wand.It has plasma on the side, and looks like its heavily damaged in some way.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found no similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.The root cause of the reported event could not be determined since findings cannot lead to a clear cause of the reported event.Factors that could have contributed to the reported event include a broken wire inside the wand cable, a damaged wire between the transition of the handle and the shaft, and damage to the shaft tip or housing.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• 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: 15996471
• Report Number: 3003604053-2022-00070
• Device Sequence Number: 5922543
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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: 04/10/2024
• Device Model Number: 7210111
• Device Catalogue Number: 7210111
• Device Lot Number: 2071708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2022
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2021
• 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
• Patient Sex: Unknown