MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC FLEXISION; BIOPSY NEEDLE, 21G

Model Number	490103-10
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ion endobronchial lung biopsy procedure, the biopsy needle would not extend out of the sheath/retract after two passes.The biopsy needle was stuck in the sheath.The diagnostic procedure was completed with no reported injury.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received a da vinci product to perform failure analysis.The biopsy needle instrument was analyzed and failure analysis investigations replicated/confirmed the customer reported complaint.Failure analysis found the primary failure of needle extension to be related to the customer reported complaint.The biopsy needle was found to have a needle extension failure.The needle would not extend out of the distal tip for all positions 1-3.The distal tip was submerged in warm water for a few minutes and after multiple attempts, the needle was still unable to extend for all positions 1-3 off the system.No damage to the ratchet indicator and handle was observed.Additional observations not reported by site were also identified: the biopsy needle was found to have a broken needle.In an attempt to extend the needle, more force than normal was applied.The handle was pushed passed position 2 and a broken needle was observed.The broken piece was not returned.The size of the broken piece was unknown.The complaint regarding would not extend was confirmed by failure analysis.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received a da vinci product to perform failure analysis.The biopsy needle was unable to be extended upon multiple attempted jabs.The biopsy needle was soaked in warm water for 3 minutes.After soaking, the needle was still unable to be extended.The sheath was observed to be nicked near the heat affected zone, approximately 5mm from the distal tip.The needle assembly was disassembled.High friction was observed between the needle shaft and the sheath, when attempting to remove the needle shaft from the sheath.The biopsy needle extension failure is likely related to the friction between the needle sheath and shaft materials.The sheath was observed to be nicked approximately 10mm from the flared end.The biopsy needle shaft was observed to be kinked near the hypotube bond.It is likely that excessive friction between the sheath and needle shaft led to excessive force being required in an attempt to extend the needle, leading to the kinked needle shaft.No damage was observed at the needle tip and no pieces were observed to be missing.In an attempt to extend the needle, more force than normal was applied.The handle was pushed past position 2 and a broken needle was observed.The broken piece was not returned.The size of the broken piece was unknown.It appeared that the needle stylet rather than the tip of the shaft is what was forcibly pushed out far enough to be observed at the distal tip of the needle.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: FLEXISION
• Common Device Name: BIOPSY NEEDLE, 21G
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 17322824
• Report Number: 2955842-2023-17056
• Device Sequence Number: 17527093
• Product Code: EOQ
• UDI-Device Identifier: 10886874115968
• UDI-Public: (01)10886874115968(10)L220009
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 06/15/2023

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: 490103-10
• Device Catalogue Number: 490103
• Device Lot Number: L220009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 10/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2022
• 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
• Patient Sex: Unknown