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

Model Number	490102-09
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Pneumothorax (2012)
Date of Event	12/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided, the cause of the reported complication has been determined to be product related.The physician reported that the 23g flexision biopsy needle was discarded and therefore will not be returned for analysis.The system logs were reviewed for the ion system (b)(4) on the procedure date of (b)(6) 2021 by an isi senior failure analysis engineer: no relevant errors were observed during this procedure.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip for the reported event was submitted for review.This event is being reported due to the following conclusion: after undergoing an ion endoluminal lung biopsy procedure, the patient reportedly sustained a pneumothorax which required the placement of a chest tube to resolve.In addition, the patient stayed in recovery three hours longer than anticipated.The customer also alleged that the 23g flexision biopsy needle sheath experienced significant movement which contributed to the patient pneumothorax.
Event or Problem Description
It was reported that during an ion endoluminal lung biopsy procedure the 23g flexision biopsy needle sheath moved significantly during the first pass made with it.On (b)(6) 2022, intuitive surgical inc.(isi) contacted the physician of this procedure and additional information was obtained about the complaint: the pneumothorax was identified sonographically (ultrasound) after the ion procedure was completed.The physician reported that they believe the 23g flexision biopsy needle contributed to the pneumothorax, but that the biopsy needle was discarded and therefore cannot be returned.The physician confirmed that 23g flexision biopsy needle sheath movement occurred during this procedure and they said the movement may have possibly caused or contributed to the pneumothorax.When asked if the physician believes this pneumothorax would have likely occurred via another biopsy modality, the physician answered: ¿can¿t answer this.¿ the physician reported that the pneumothorax was moderate in size, and was probably a onetime leak that, once it was drained completely, did not recollect.The patient experienced chest pain and hypoxic respiratory failure.When asked if the patient was ever considered medical unstable the physician provided the following answer: ¿ just prior to the chest tube her saturations were in the low 80's which improved gradually after drainage.¿ the patient was not admitted to the hospital, but stayed in recovery three hours longer than anticipated and discharged after the chest tube was removed.The physician reported placing the chest tube for the purpose of evacuating the air from the chest cavity and resolving the pneumothorax.The patient was reportedly discharged with the pain resolved.
Additional Manufacturer Narrative
Updated information can be found in the following fields: g3, g6, and h2.Corrected information can be found in the following field: b1.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
On (b)(6) 2022, intuitive surgical, inc.(isi) contacted the physician of this procedure and additional information was obtained about the complaint: the physician reported that the 23g flexision biopsy needle involved with the alleged sheath movement was the first needle used during this procedure and the movement occurred during the first pass with the needle.The physician reported the needle was locked in place and the sheath and needle moved unexpectedly about 3 to 3.5mm.The physician said they intended to jab about 1.5 to 2mm¿s during this event.The physician reported seeing the needle sheath moving out from the catheter during this event.The physician said the external components of the flexision 23g biopsy needle looked normal.The physician clarified that the catheter stayed in place, but the needle and needle sheath moved further than the physician anticipated.The physician reported that they do not believe they were jabbing harder than normal.The physician removed the flexision 23g biopsy needle after this event, inspected it and found no abnormalities, then discarded it.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: FLEXISION
• Common Device Name: BIOPSY NEEDLE, 23G
• 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: 13322743
• Report Number: 2955842-2022-10112
• Device Sequence Number: 13865110
• Product Code: EOQ
• UDI-Device Identifier: 00886874115954
• UDI-Public: (01)00886874115954(17)230630(10)S90210617
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2021

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: 490102-09
• Device Catalogue Number: 490102
• Device Lot Number: S90210617
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 01/13/2022; 02/09/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 02/11/2022; 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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 Age: 40 YR
• Patient Sex: Female
• Patient Weight: 103 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White