MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES ANSPACH FOOT CONTROL; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number 120041

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

The device used for treatment was returned for evaluation.Nothing was identified visually that contributed to the problem.The connector pins are in an extended position and straight.A functional evaluation was performed.The reported problem was confirmed.The footswitch has no control over the drill function.The footswitch is not recognized at the case connection screen.A review of manufacturing and service records indicate the device met all specifications upon release into distribution.A complaint history review for similar reported/confirmed complaints associated with the anspach footpedal and failure mode identified similar events.The most likely cause of this event is a mechanical or electrical failure of the device.The device is an oem part and cannot be further disassembled to arrive at a root cause.No further containment or corrective actions are recommended at this time.

Event Description

It was reported that anspach foot control is not working and cable is broken right behing the blue handpiece.No patient injuries or delays involved.

• Brand Name: ANSPACH FOOT CONTROL
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2905 northwest blvd ste 40; plymouth MN 55441
• Manufacturer Contact: rick confer ; 2828 liberty ave; suite 100; pittsburgh, PA 38116 ; 4126833844
• MDR Report Key: 10504965
• MDR Text Key: 206130322
• Report Number: 3010266064-2020-01749
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K080802
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 120041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NPFS02020, NAVIO SURGICAL SYSTEM, SN(B)(4).