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

Model Number	7209686
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
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 procedure, the tip and the shaft of the probe saphyre wand, got separated when used for 5 minutes.The procedure was successfully completed with a non-significant surgical delay using a back-up device.No further complications were reported.
Additional Manufacturer Narrative
H3, h6: the reported device was received for evaluation.There was a relationship found between the device and the reported event.A visual inspection revealed the device was returned without original packaging.The distal tip was deformed and the active electrode was broken off.The cable was cut.A functional evaluation could not be performed due to the condition of the returned device.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found no similar reported events.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 and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A clinical evaluation was performed and the provided image was reviewed.Based on the report of "no further complications" and the limited clinical information provided, no further clinical assessment is needed at this time.The complaint was confirmed and the root cause was associated with a component failure.Factors that could have contributed to the reported event include impact or inappropriate force exerted on the distal tip.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.

• Brand Name: PROBE SAPHYRE 90DEG
• 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: 15791903
• Report Number: 3003604053-2022-00068
• Device Sequence Number: 5747569
• Product Code: GEI
• UDI-Device Identifier: 03596010470560
• UDI-Public: 03596010470560
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2022

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: 04/10/2024
• Device Model Number: 7209686
• Device Catalogue Number: 7209686
• Device Lot Number: 2070674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2022
• Supplement Date Received by Manufacturer: 11/28/2022
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 11/29/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female