MAUDE Adverse Event Report: BLUE BELT TECHNOLOGIES ANSPACH FOOT CONTROL; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 120041

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2019

Event Type  malfunction  

Event Description

It was reported that, during an ukr surgery, the anspach foot pedal did not connect: it was unplugged and repluged and kept working as intended.Surgery was not delayed.The patient was not injured.

• Brand Name: ANSPACH FOOT CONTROL
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): BLUE BELT TECHNOLOGIES
• Manufacturer (Section G): BLUE BELT TECHNOLOGIES; 2875 railroad street; pittsburgh PA
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735
• MDR Report Key: 11219107
• MDR Text Key: 228358328
• Report Number: 3010266064-2021-00053
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• 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
• Date Manufacturer Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1