MAUDE Adverse Event Report: HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L. TRUNODE; PROBE, UPTAKE, NUCLEAR

Model Number 120-807606

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 07/08/2022

Event Type  malfunction  

Event Description

Inaccurate reading of the trunode box.Turned off machine and restarted.Numerical values received were not in alignment with what was clinically expected.Fda safety report id # (b)(4).

• Brand Name: TRUNODE
• Type of Device: PROBE, UPTAKE, NUCLEAR
• Manufacturer (Section D): HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L.
• MDR Report Key: 15104561
• MDR Text Key: 296691135
• Report Number: MW5111106
• Device Sequence Number: 1
• Product Code: IZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 120-807606
• Device Catalogue Number: 120-807606
• Device Lot Number: 22C17RA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Race: White