MAUDE Adverse Event Report: THE ANSPACH EFFORT LLC ELECTRIC SYSTEMS FOOT CONTROL WITH DIR; MOTOR, DRILL, ELECTRIC - FOOT CONTROL

Model Number	E-FP-DIR
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned for evaluation.Reliability engineering evaluated the device and determined that the cord was damaged and wires were exposed preventing the function test from being performed.It was noted that the hole in the cord is due to mishandling of the device by allowing the cord to come into contact with a sharp object which punctured the cord or exerting extreme force on the cord during cleaning or use.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to mishandling which is user error.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Event or Problem Description
It was reported that the foot control device had wires exposed.It was not reported whether this event occurred during surgery or whether a spare device was available for use.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: ELECTRIC SYSTEMS FOOT CONTROL WITH DIR
• Common Device Name: MOTOR, DRILL, ELECTRIC - FOOT CONTROL
• Manufacturer (Section D): THE ANSPACH EFFORT LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7065013
• Report Number: 1045834-2017-50037
• Device Sequence Number: 102422
• Product Code: HBC
• UDI-Device Identifier: 00845384011750
• UDI-Public: (01)00845384011750(11)110808
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K080802
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/30/2017

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: E-FP-DIR
• Device Catalogue Number: E-FP-DIR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2017
• Initial Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1