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

Model Number TRUNODE S-10

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 06/03/2021

Event Type  malfunction  

Event Description

During a sentinel lymph node biopsy, the gamma probe seemed to be acting overly sensitive and erratic.After dissection of the specimen, the probe would no longer register it.Another probe was opened when tested on the tissue, it appeared to have accurate readings.The case continued without incident.

• Brand Name: HOLOGIC TRUNODE
• Type of Device: PROBE, UPTAKE, NUCLEAR
• Manufacturer (Section D): FAXITRON BIOPTIC, LLC / HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L. ; 250 campus dr. ; marlboro MA 01752
• MDR Report Key: 12016675
• MDR Text Key: 257408853
• Report Number: MW5101950
• Device Sequence Number: 1
• Product Code: IZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: TRUNODE S-10
• Device Lot Number: 090120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 105