MAUDE Adverse Event Report: HOLOGIC, INC. FLUOROSCOPY X-RAY

Device Problems Inadequate Instructions for Healthcare Professional (1319); Protective Measures Problem (3015)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 10/03/2016

Event Type  Other  

Event Description

I'm writing to you today to express a concern about the perception of radiation of radiation risk from mini c arms in the medical community.I have been doing some research into standard notices and radiation safety practices.I have informally interviewed staff (rns, surgical techs, anesthesia, etc) at several hospitals and ambulatory surgery centers who are exposed to radiation these devices and there is a pervasive belief that they do not pose the same level of risk as the "big c arm".Therefore they do not follow standard protective procedures that they always follow with the "big c arm".These medical professionals are trained at different facilities across the nation and combined have literally hundreds of person years of experience.They just do not believe that the devices pose a significant risk.I also do not believe you can address the problem with enforcement actions - this is fundamentally a re-education issue that has to be addressed on a state wide scale very quickly.I think that the most successful approach would be to send a letter to every registrant of a mini c-arm device, explicitly that standard radiologic safety procedures must be followed with the mini c-arm to ensure employee safety.This would be inexpensive and very effective.I used this technique at one facility i visited and it was very effective once the medical director understood the implications.Than you for your consideration.

• Brand Name: FLUOROSCOPY X-RAY
• Type of Device: FLUOROSCOPY X-RAY
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 6017090
• MDR Text Key: 57265234
• Report Number: MW5065284
• Device Sequence Number: 1
• Product Code: JAA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/06/2016

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/06/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 81