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

Model Number	7210111
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference case (b)(4).
Event or Problem Description
It was reported that during arthroscopy procedure, inside the patient, the spinal injection system 20ga was getting hot.The customer continuously used the device to wrap a gauze which is wet with water, on the handle of the probe.The customer stopped using the probe since the device gave out smoke from the tip.The procedure was successfully completed with a smith and nephew back-up device.No surgical delay.No patient injuries.
Additional Manufacturer Narrative
B5, event description: updated.
Event or Problem Description
It was reported that during arthroscopy procedure, inside the patient, the handle of the saphyre probe was getting hot.The customer continuously used the device to wrap a gauze which is wet with water, on the handle of the probe.The customer stopped using the probe since the device gave out smoke from the tip.The procedure was successfully completed with a smith and nephew back-up device.No surgical delay.No patient injuries.
Additional Manufacturer Narrative
D1, brand name: corrected.
Additional Manufacturer Narrative
The reported device was received for evaluation.It was determined the device contributed to the reported event.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.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 the device returned outside its original packaging.The handle of the probe had a bulge, causing the plastic weld to fail in that location and expose the inner components to outside fluids or materials.The electrode had dark discoloration from use.A functional evaluation found the device did not overheat or smoke after an extended use of bipolar ablation (cut at 160 for 90 sec).Both cut and coag modes provided ablation appropriately.The complaint was confirmed and the root cause associated with a component failure.Factors that could have contributed to the reported event include overuse of the probe or ingress of moisture into the handle which could have caused an electrical short and could have caused the handle to heat.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 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: 12175835
• Report Number: 3003604053-2021-00232
• Device Sequence Number: 936333
• Product Code: GEI
• UDI-Device Identifier: 03596010481498
• UDI-Public: 03596010481498
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/25/2022

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: 05/04/2023
• Device Model Number: 7210111
• Device Catalogue Number: 7210111
• Device Lot Number: 2055608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 06/28/2021; 06/28/2021; 04/22/2022
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 12/15/2021; 01/11/2022; 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2020
• Is the Device Labeled for Single Use? (Y/N): No
• 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