MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR FOOT PEDAL

Model Number	FSENCOR01
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to bd for evaluation.The investigation is identified as inconclusive as the device was not returned.Based on the information provided, the definitive root cause is unknown.The device is labeled for reuse.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model fsencor01 encor allegedly experienced unintended movement.This information was received from one source.This malfunction did involve a patient with no patient injury.The patient age, gender, and weight was no provided.

• Brand Name: ENCOR FOOT PEDAL
• Common Device Name: ENCOR
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9203204
• Report Number: 2020394-2019-04060
• Device Sequence Number: 3107089
• Product Code: KNW
• UDI-Device Identifier: 00801741086557
• UDI-Public: (01)00801741086557
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2019

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: No Information
• Device Model Number: FSENCOR01
• Device Catalogue Number: FSENCOR01
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/17/2019
• Patient Sequence Number: 1