MAUDE Adverse Event Report: NUCLETRON B.V. MICROSELECTRON; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number 189628

Device Problems Break (1069); Crack (1135); Material Twisted/Bent (2981); Insufficient Information (3190)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer's investigation is on-going and further information will be provided once the investigation has been completed.

Event Description

The customer reported that a proguide obturator was broken in the patient body.

Manufacturer Narrative

B1 updated information b3 added date.D9 updated information.H3 updated information.H6 updated coding.H7 new information.H10 added information.The investigation was completed by conducting a thorough evaluation of the product and the reported information.During the needle insertion for prostate treatment, a proguide obturator broke outside the patient.In addition, one proguide obturator was bent.A detailed analysis of the broken obturator regarding the material structure and chemical composition did not show any deviation or difference with sample material.Bending tests on sample material resulted in similar breakage patterns as in the returned obturator.Based on these test results, the root cause of the breakage was determined to be excessive lateral force during handling and insertion of the obturators.When large bending forces are applied on the obturators, cracks can appear, from which the obturators can break.In this case, the user used excessive (lateral) force on the obturator during needle insertion, which resulted in the obturator to break (outside the patient's body).Excessive lateral forces should be avoided during the handling of obturators.The broken obturator was replaced.This event is caused by use error and is considered as accidental.There was no injury to the patient.Elekta assessed the severity of risk to be non-serious.

• Brand Name: MICROSELECTRON
• Type of Device: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): NUCLETRON B.V.; waardgelder 1; veenendaal 3905 TH; NL 3905 TH
• MDR Report Key: 10419385
• MDR Text Key: 203305188
• Report Number: 9611894-2020-00003
• Device Sequence Number: 1
• Product Code: JAQ
• UDI-Device Identifier: 08717213051140
• UDI-Public: 08717213051140
• Combination Product (y/n): N
• PMA/PMN Number: K060349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 189628
• Device Lot Number: 1000156940
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1