MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENTRYGUIDE; KIT, C.6.6.6 (STANDARD)

Model Number	430022-10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the claim against the product by the customer noting physical damage on the entry guide, an investigation was completed to determine the cause of this reported event.Intuitive surgical, inc.(isi) received the entry guide involved with this complaint and completed the device evaluation.Failure analysis confirmed that the entry guide was returned with two levers and the funnel dislodged from its normal position.This is consistent with the customer reported event.The root cause of this failure is attributed to mishandling and misuse.As part of the investigation, visual inspection also identified a dislodged sheath coextrusion in the entry guide shaft.The information gathered indicates that the device did contribute to the customer reported issue.This is considered a reportable event due to the following conclusion: it was alleged that the entry guide broke, and a fragment fell inside the patient during a da vinci-assisted procedure.The fragment was retrieved during the same procedure without further impact or patient consequence reported.Failure analysis confirmed the issue, and the root cause is indicative of mishandling/misuse.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure using a single port (sp) system, physical damage was observed during insertion of the entry guide kit.A piece fell inside the patient as a result.The entry guide was removed and the entire piece was retrieved.The user completed the procedure with no further issue reported.No known impact or patient consequence was reported.Intuitive surgical, inc.(isi) followed up and obtained the following additional information: according to the robotics coordinator, the entry guide kit was inspected prior to use and there were no defects that were noted.At the time of the reported event, the monopolar curved scissors instrument was being inserted into the entry guide, and the surgeon confirmed that the entry guide broke and a piece from the entry guide fell inside the patient's abdomen.When the reported issue occurred, the instrument was being inserted and had not been used yet.The surgeon did not notice any functionality issues during the surgical procedure.There was no collision with another instrument or hard material.The fragments were retrieved by the assistant who used a port to grab and remove it from the patient, and to the best of the knowledge of the surgeon all fragments were retrieved.There was no additional surgical procedure that was required to remove the fragment.There were no post-operative tests like an x-ray or ultrasound performed to check for remaining fragments.The da vinci robotics coordinator was not aware if the patient experienced any post-surgical complications.
Additional Manufacturer Narrative
Further investigation was performed by an intuitive surgical, inc.(isi) failure analysis engineer (fae).It was confirmed that the returned fragment appeared to be a sheath distal coextrusion as it strongly matched the appearance in color, size and diameter when referenced to an in-house sheath's coextrusion.The coextrusion did not have evidence of being torn or ripped from an instrument sheath.The coextrusion's surface had light impressions of the surface, potentially from the retrieval of the fragment during the procedure.The surface was otherwise clean and did not appear to have any surface residue.There was no issue with the entry guide that could cause the coextrusion to dislodge.It was also identified that the entry guide was returned partially disassembled, and no piece appeared to be missing.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENTRYGUIDE
• Common Device Name: KIT, C.6.6.6 (STANDARD)
• 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: 16550361
• Report Number: 2955842-2023-11319
• Device Sequence Number: 6007412
• Product Code: NAY
• UDI-Device Identifier: 10886874113506
• UDI-Public: (01)10886874113506(10)K10220922
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2023

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: 430022-10
• Device Catalogue Number: 430022
• Device Lot Number: K10220922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2023
• Supplement Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 03/15/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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: Unknown
• 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: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown