MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; VESSEL SEALER

Model Number	410322-05
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has requested that the vessel sealer instrument be returned for evaluation, but it has not yet been returned.Therefore, the root cause of the customer reported failure mode has not been determined.A follow-up mdr will be submitted if the product is returned and evaluated and/ or if additional information is received.A review of the site's complaint history does not show any additional complaints for this product.No image or procedure video was provided for review.A log review for the vessel sealer instrument could not be performed because the lot # was not provided by the customer.This complaint is being reported based on the following conclusion: it was reported that the vessel sealer instrument grips did not open while inside the patient.Medical intervention may be required in the event that the endowrist vessel sealer fails to unclamp from tissue when commanded by the user or system.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.Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable.The expiration date is not applicable.Implant date is blank because the product is not implantable.Pma/510(k) number and adverse event are not applicable.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the jaws of the vessel sealer instrument broke and did not open anymore.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter on (b)(6) 2022 and (b)(6) 2022, and obtained the following additional information: the doctor confirmed that the vessel sealer jaws were not stuck on tissue and the instrument was removed from the tissue as usual.No fragments fell inside that patient.A backup instrument was used to proceed with the surgical task.As a result of the alleged issue, there was a procedural delay of 80 minutes.There was no broken cable observed.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the vessel sealer instrument associated with this complaint and completed investigations.Failure analysis (fa) investigations did not replicate nor confirm the customer reported complaint.After retracting the blade, the vessel sealer instrument was placed and driven on an in-house system.The instrument passed the self-test homing.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly.The instrument passed the knife slot test.An additional observation that was not reported by the site and was not related to the customer reported complaint was also identified.The vessel sealer instrument was found to have dislodged blade.Visual inspection showed that the blade was exposed outside of the blade garage 0.131".No conductor wire damage or snake wrist damage was found.There was no bio debris found at the instrument tip.A review of the logs showed an blade exposed failure.The root cause of the dislodged instrument blades is typically attributed to mishandling/ misuse.The vessel sealer instrument was found to have a self-test homing failure during in-house testing.Before retracting the blade, the instrument was placed on an in-house system.The instrument failed the self-test homing.This failure was a result of the dislodged blade failure of the instrument.The root cause of this failure is attributed to mishandling/misuse.A review of the instrument log for the vessel sealer instrument (part number 410322-05/lot number m10210726 494) associated with this event has been performed.Per logs, the vessel sealer instrument was last used in a procedure on 31-march-2022 on system (b)(6).
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: VESSEL SEALER
• 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: 14265791
• Report Number: 2955842-2022-11384
• Device Sequence Number: 4438648
• Product Code: NAY
• UDI-Device Identifier: 10886874111113
• UDI-Public: (01)10886874111113(10)M10210726
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110639
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2022

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: 410322-05
• Device Catalogue Number: 410322
• Device Lot Number: M10210726 494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 05/03/2022
• Supplement Report FDA Received Date: 07/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2021
• 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: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 93 KG