MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC FLEXISION; BIOPSY NEEDLE, 19G

Model Number	490104-15
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.Failure analysis investigations replicated/confirmed the customer-reported complaint.The primary failure of the kinked needle was found to be related to the customer-reported complaint.The biopsy needle was found to have a kinked needle approximately 4.73mm from the sheath tip.Failure analysis also found the secondary failure of needle retraction failure to be related to the customer-reported complaint.The biopsy needle was found to have a needle retraction failure, with friction observed during multiple attempts at needle extension and retraction.The needle failed to fully retract back into the sheath tip, protruding approximately 4.73mm outside.Functional tests could not be performed due to the return condition of the biopsy needle.Additional observations not reported by the site include the sheath tip deformity of the biopsy needle, with delamination at the distal sheath tip.The root cause of this failure is attributed to manufacturing.The biopsy needle was also found to have excess, damaged material near the kink damage location.This rma was transferred to engineering for further investigation of the damaged material on the needle and to determine any missing fragments.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Field e4 is blank because it is unknown if the initial reporter submitted a report to the fda.Fields g5 and g7 are not applicable.
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, the customer reported the tip of biopsy needle instrument was broken.The diagnostic procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on and obtained the following additional information: the biopsy needle was not used on the patient.The needle was a newly opened needle.The patient has not returned to the hospital due to experiencing any post-surgical complications related to retaining a foreign object.
Additional Manufacturer Narrative
The biopsy needle was reviewed by an ion biopsy needle design engineer and ion biopsy needle quality engineer.Flexible needle tip was observed to be kinked approximately 5.3mm from the distal tip of the needle.The slots in the flexible needle were observed to be slightly deformed at the location of the kink, but metal remained intact.Needle was unable to be fully retracted due to the kinked needle.Pet damage was observed approximately 4.4mm from the distal tip.Pet was observed to be bunched and torn.Due to the pet being bunched and torn it is unable to be confirmed whether there are any missing pieces of pet.Per follow-up information received, "the biopsy needle was not used on the patient.The needle was a newly opened needle." the needle is packaged inside a tray with the needle shaft inside a tube that is held in the tray.Based on the packaging configuration, root cause is unlikely to be related to transport or packaging.After sterilization of the needle inside of its packaging, a 100% x-ray inspection is performed to verify that the needle tip is located inside the sheath tip.Per ion biopsy needle quality engineer, there were no failures at x-ray inspection.As a result, root cause is unlikely to be due to manufacturing based on the unit passing the x-ray inspection.Per design engineer, the needle can become kinked prior to use due to improper handling when the user removes the needle from the packaging.Pet damage could be due to the user trying to extend and retract the needle after it had been kinked.Kinked needle and damaged pet are most likely attributed to mishandling prior to use and is attributed to the user.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: FLEXISION
• Common Device Name: BIOPSY NEEDLE, 19G
• 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: 20164709
• Report Number: 2955842-2024-19153
• Device Sequence Number: 12571422
• Product Code: EOQ
• UDI-Device Identifier: 00886874115978
• UDI-Public: (01)00886874115978(11)231102(17)251130(10)S11231102
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K182188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2024

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: Other
• Device Model Number: 490104-15
• Device Catalogue Number: 490104
• Device Lot Number: S11231102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 09/07/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• 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: Reuse
• 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.
• Patient Sex: Prefer Not To Disclose