MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; CURVED BIPOLAR DISSECTOR

Model Number	420344-06
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The curved bipolar dissector instrument was requested to be returned, but it has not yet been received by isi for evaluation.Therefore the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.A review of the instrument log for the curved bipolar dissector instrument 420344-06 / n10160823-401 associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2021 on system (b)(4) for approximately 2 minutes.The alleged issue was identified on (b)(6) 2021 prior to starting a procedure so the instrument was not used.A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event.This complaint is being reported due to the following conclusion: the instrument's pin was dislodged.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
Event or Problem Description
It was reported that prior to starting (pre anesthesia) a da vinci-assisted surgical procedure, when opening the curved bipolar dissector instrument, a loose pin was identified.A backup instrument of a different type was used and the procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the customer and obtained the following additional information: when the package was opened the loose pin was identified so the instrument was not used for the procedure as it was withdrawn from use.
Event or Problem Description
Refer to h10/h11 for follow-up information.
Additional Manufacturer Narrative
D10 - intuitive surgical, inc.(isi) received the curved bipolar dissector instrument involved with this complaint and completed the device evaluation.Failure analysis investigations did not replicate nor confirm the customer reported complaint.The instrument was inspected and did not find damaged, dislodged, or loose grip pin or clevis pin.The instrument was placed and driven on a test system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The grip pin and clevis pin did not move during the opening and closing of the grip tips.The instrument was fully functional.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: CURVED BIPOLAR DISSECTOR
• 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: 13564914
• Report Number: 2955842-2022-10298
• Device Sequence Number: 16608648
• Product Code: NAY
• UDI-Device Identifier: 00886874111840
• UDI-Public: (01)00886874111840(10)N10160823
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2022

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: 420344-06
• Device Catalogue Number: 420344
• Device Lot Number: N10160823 401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2016
• Is the Device Labeled for Single Use? (Y/N): No
• 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: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown