MAUDE Adverse Event Report: NUCLETRON B.V. TROCAR POINT TITANIUM NEEDLE SETS; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number	189989P01-00
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer's investigation is on-going and further information will be provided once the investigation has been completed.
Event or Problem Description
The customer reported that the tip of the trocar needle broke and was stuck inside the patient.Surgical camera was used to assist the removal of the tip of the needle.The patient was discharged with an antibiotic medicine.
Additional Manufacturer Narrative
G1-2 contact office: address updated.H6 added coding.H7 added information.The investigation was completed by conducting a thorough evaluation of the product and the reported information.The returned needles were examined and it was found that the needles were badly deformed and showed signs of repeated bending and straightening.The needle with the broken tip had multiple bends.There were no signs of mechanical deformation or wear and there was no visible solder or heat print/discolouration present.The tips of the other returned needles were all fixated properly and also showed no solder or heatprint at the transition.There is no indication of a manufacturing issue.The needles were in use since august 2016 and are past its life expectancy.The information provided in the 'instructions for use' states that the packaging and shelf life of the product should be regularly inspected and if needles become deformed they should be removed from clinical use.The needles have been replaced.
Additional Manufacturer Narrative
Section g7: report was submitted as follow-up 2 due to an error identified in follow-up 1.Section e1 reporter name and address: united states was selected in follow-up 1 report but should have been thailand.It has been corrected in this follow-up report.Section h2: correction ticked.

• Brand Name: TROCAR POINT TITANIUM NEEDLE SETS
• 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: 10008721
• Report Number: 9611894-2020-00001
• Device Sequence Number: 19536420
• Product Code: JAQ
• UDI-Device Identifier: 08717213020788
• UDI-Public: 08717213020788
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K080871
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/29/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 189989P01-00
• Device Lot Number: 1000064515
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 03/31/2020; 03/31/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 07/29/2020; 07/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1