MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC FLEXISION; BIOPSY NEEDLE, 23G

Model Number	490102-15
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A return material authorization (rma) was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.As of the date of this report, the product has not yet been received.A review of the provided image was performed.It appeared that there may be a metal piece in the distal end of the et tube.However, without having a better-quality image of the et tube and an image of the needle itself, it cannot be concluded if it is indeed a metal fragment and if was generated from the needle.It would be best for the needle to be returned on an rma for investigation to determine whether there are any broken/missing pieces.Root cause of the failure mode cannot be confirmed without the returned device.
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, the physician did not have access to a linear endo-bronchial ultrasound (ebus) scope, so used the ion for a mediastinal staging of a 4r node (right lower paratracheal lymph node).After the biopsy, it was seen with the camera that part of the needle broke off and was lodged into the endotracheal (et) tube.After extubating, the part of the needle was still in the tube.There was no delay.The physician was well aware that ion was not for staging.The diagnostic procedure was completed.Intuitive surgical, inc.(isi) obtained the following additional information from the manager of clinical applications engineering: the medical personnel stated that they threw the et tube with the fragment away and did an airway survey after and did not see any other fragments in the airway.The patient was doing well in recovery.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the biopsy needle involved with the reported event and performed failure analysis evaluation.The biopsy needle was found to have a detached needle tip.Per the customer complaint, the needle tip had been lodged into the endotracheal (et) tube.The needle tip fragment was not returned and approximately 5mm of the distal tip was not present.When the needle stop was set to positions 1, 2, and 3, the grey handle was moved distally to extend the needle out.The needle was repeatedly extended and retracted with no issues.A visual inspection was performed, and no kinks were found on the shaft.The biopsy needle is not indicated for lymph node staging.The needle assembly was disassembled.No damage was observed to the thumbscrew pin or the connector body.The remaining portion of flexible needle tip was observed to be kinked approximately 4mm from the broken end.The needle can become kinked during its extension with a tight tip bend radius or aggressive jabbing.Additionally, biodebris was observed along the needle from the broken end of the flexible needle tip to approximately 101mm proximal of the broken end.

• Brand Name: FLEXISION
• Common Device Name: BIOPSY NEEDLE, 23G
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 20447154
• Report Number: 2955842-2024-20357
• Device Sequence Number: 8532394
• Product Code: EOQ
• UDI-Device Identifier: 00886874115954
• UDI-Public: (01)00886874115954(11)231120(17)251130(10)S11231120
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K182188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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: 490102-15
• Device Catalogue Number: 490102
• Device Lot Number: S11231120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ION ENDOLUMINAL SYSTEM.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown