MAUDE Adverse Event Report: ELEKTA INSTRUMENT AB DISPOSABLE BIOPSY NEEDLE 6 KIT

Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/25/2024
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 completed.
Event or Problem Description
The customer reported that they suspected biopsy needles to be contaminated.
Additional Manufacturer Narrative
H6 updated.H11 updated: elekta has become aware that disposable biopsy needles (911933) from one batch (873874875r) can contain some microscopic debris on the inside of the biopsy needle.The material in the debris is stainless steel, same material as the biopsy needle.No debris has been found on the outer parts of the biopsy needles.The sterility of the biopsy needles has not been affected.This issue has been reported from one site.There is a risk that debris can come loose and appear in the biopsy sample.Debris in the biopsy sample may interfere with the slicing of the biopsy sample and delay or make examination difficult.There is also a potential risk that debris is deposited in the brain.This risk is considered very low since debris have only been reported on the inside of the biopsy needle.With investigations with the supplier the root cause is that the debris originates from the manufacturing process, but we have not been able to identify from which step.As a mitigiation we have stopped production until this is confirmed.This issue has been seen from one customer site.There have been no other reported cases.An important field safety notice 100-01-301-010 was sent to all affected customers on 25th september 2024.

• Brand Name: DISPOSABLE BIOPSY NEEDLE 6 KIT
• Common Device Name: DISPOSABLE BIOPSY NEEDLE 6 KIT
• Manufacturer (Section D): ELEKTA INSTRUMENT AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer (Section G): ELEKTA INSTRUMENT AB; hagaplan 4; stockholm, 113 6 8; SW 113 68
• Manufacturer Contact: cornerstone; london road; crawley, west sussex RH10 -9BL
• MDR Report Key: 20046547
• Report Number: 9612186-2024-00002
• Device Sequence Number: 12746121
• Product Code: HAW
• UDI-Device Identifier: 07340048300346
• UDI-Public: 07340048300346
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K152558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown