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

Model Number	7210111
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during an arthroscopy, the insulation rubber of the saphyre ii probe fell off.The fallen off rubber was removed by suction.The procedure was completed using a back-up device.It is unknown if there was a delay.No further complications were reported.
Event or Problem Description
It was reported that during an arthroscopy, the insulation rubber of the saphyre ii probe fell off.The fallen off rubber was removed by suction.The procedure was completed with non-significant surgical delay and was finished with a smith and nephew back up device.No further complications were reported.
Additional Manufacturer Narrative
H10, h6: a device deficiency was identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.The instructions for use were 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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical review states that two undated photos where provided for review and confirm the reported insulation rubber removal.Per case details, the rubber from the wand was retrieved from the patient.The procedure was completed using a back-up device.No patient injuries or adverse consequences were reported.Since no patient injuries are being reported no further clinical/medical assessment is warranted at this time.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.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: 14876856
• Report Number: 3003604053-2022-00022
• Device Sequence Number: 12220410
• Product Code: GEI
• UDI-Device Identifier: 03596010481498
• UDI-Public: 03596010481498
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2023

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: 03/18/2024
• Device Model Number: 7210111
• Device Catalogue Number: 7210111
• Device Lot Number: 2070677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Supplement Date Received by Manufacturer: 07/07/2022; 06/01/2023
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 07/11/2022; 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2021
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 68 KG