MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTSWITCH EP-1 PEDAL STYLE; ARTHROSCOPE

Model Number	7205396
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Event or Problem Description
It was reported that during set up for a knee scope, the foot pedal was sticking.The sticking issue cause the device to run unintended.The procedure was successfully completed without delay using a smith and nephew back up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
H10: internal complaint reference: (b)(4).H3, h6: the reported device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.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 concluded this was a repeat issue.A visual inspection was performed and no deficiencies were observed.The reported malfunction was not observed during functional evaluation.The complaint was not verified and the root cause could not be determined since the reported malfunction could not be duplicated during the product evaluation process.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: FOOTSWITCH EP-1 PEDAL STYLE
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 76 s. meridian ave.; oklahoma city OK 73107
• MDR Report Key: 12131760
• Report Number: 1643264-2021-02187
• Device Sequence Number: 3713455
• Product Code: HRX
• UDI-Device Identifier: 03596010251961
• UDI-Public: 03596010251961
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K892062
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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 Model Number: 7205396
• Device Catalogue Number: 7205396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1