MAUDE Adverse Event Report: NUCLETRON B.V. UTRECHT INTERSTITIAL CT/MR FLETCHER APPLICATOR; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number	110270A02-01
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Oversedation (1990); Foreign Body In Patient (2687)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going.Further information will be provided once the investigation has completed.The customer informed that the patient was given an additional anaesthetic to remove the broken probe and as a precautionary measure has been given antibiotics.There was no injury to the patient.
Event or Problem Description
The customer reported that a uterine probe 15° broke after placement in the patient, between surgery and mri before treatment.
Additional Manufacturer Narrative
The investigation was completed by conducting a thorough evaluation of the product and the reported information.The returned applicator has been inspected and shows a brittle breakage surface.Tests have shown that the most likely cause of the fracture is an error during the bending process in manufacturing that leads to stress cracks in the material.Subsequent sterilization and bending during insertion can then result in breakage of the applicator.The hazardous situation of a patient's exposure to sharp device parts damaging tissue is determined to have a severity of 'insignificance', with the probability of occurrence of harm as 'implausible' (non-serious).The patient was given additional general anaesthesia during the procedure.Due to a risk of a vaginal wound (however, this was not observed during the withdrawal of the applicator) and a risk of nosocomial infection, the physician prescribed antibiotic therapy as a precaution.No adverse events caused by an applicator breakage are known to elekta.

• Brand Name: UTRECHT INTERSTITIAL CT/MR FLETCHER APPLICATOR
• Common Device Name: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): NUCLETRON B.V.; waardgelder 1; veenendaal 3905 TH; NL 3905 TH
• MDR Report Key: 10337262
• Report Number: 9611894-2020-00002
• Device Sequence Number: 3167887
• Product Code: JAQ
• UDI-Device Identifier: 08717213034648
• UDI-Public: 08717213034648
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091154
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 110270A02-01
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 05/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR