MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST SP; CADIERE FORCEPS

Model Number	430009-52
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the single port cadiere forceps instrument involved with this complaint and completed the device evaluation.Failure analysis could not replicate, nor confirm, the reported complaint.The instrument was installed onto an in-house system for functional testing.The instrument¿s grip tips opened and closed properly, however, when all of the other orientations (pitch, yaw and roll) were tested, the instrument was not moving intuitively.Additional observations not reported by the customer: the instrument was found to have a broken snake wrist cable at the distal end.The broken cable segment that contains the crimp was missing from the snake wrist disk.The root cause of broken snake wrist cable is attributed to a component failure.Further visual inspection of the distal end found the joggle tube to be broken.The tube was severely bent, causing it to snap and dislodge from the snake wrist disk.No pieces were missing.The broken joggle tube would not allow the instrument to move intuitively.The root cause of the broken joggle tube was not established.No image or video clip for the reported event was available for review.A review of the instrument log for the single port cadiere forceps (part number: 430009-52 / lot number: s10181116-0003) associated with this event has been performed.Per logs, the instrument was last used on (b)(6) 2022 on system (b)(4) for a pyeloplasty procedure.The alleged event occurred on the 14th use of the instrument.This last usage of the device was before the reported event date, this complaint is considered a reportable event due to the following conclusion: it was alleged that the single port cadiere forceps instrument moved with unintuitive motion.Poor instrument control could result in unintuitive motion and subsequent tissue damage.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 during a da vinci-assisted pyeloplasty surgical procedure that the single port cadiere forceps instrument control was reversed.When attempting to move right, the instrument moved left.When attempting to move the instrument up, it would move down.The procedure was completed with no reports of patient injury.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information, however, no further details have been received as of the date of this report.
Additional Manufacturer Narrative
Additional information found in: g6, g6, and h2.Analysis information can be found in: h6, and h10.The instrument was transferred to engineering for further investigation.The initial failure analysis investigation was confirmed.The instrument was found to exhibit non-intuitive motion.The instrument was visually inspected and it was found that the joggle tube was bent and buckled, causing it to dislodge partially from the snake wrist.No pieces were missing, and the tube did not appear to be broken, just severely bent.The joggle tube was buckled in a way that it clamped onto the wrist cables, causing the distal wrist (past the joggle tube) to be seized.When the instrument was installed on an in-house system, the instrument passed engagement and recognition tests without issues, and was able to be advanced into the cannula.The instrument was oriented in a position where the snake wrist (the wrist between the distal main tube and joggle tube) was bent.While controlling the roll direction with the master tool manipulator (mtm), it was observed that around the middle of the extremes for the roll direction that the instrument grips would break hooping and rotate in a circle non-intuitively.The motion was unexpected, as the expectation was for the instrument grips to rotate, but instead the entire distal end rotated.The root cause for the non-intuitive motion was the buckled joggle tube clamping onto the cables.The root cause for the buckled/bent joggle tube is typically attributed to mishandling/misuse and can be caused when excessive force is applied to the instrument.
Event or Problem Description
Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST SP
• Common Device Name: CADIERE FORCEPS
• 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: 15332226
• Report Number: 2955842-2022-13783
• Device Sequence Number: 17897765
• Product Code: NAY
• UDI-Device Identifier: 00886874115213
• UDI-Public: (01)00886874115213(10)S10181116
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

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: 430009-52
• Device Catalogue Number: 430009
• Device Lot Number: S10181116 0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2018
• 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 Age: 83 YR
• Patient Sex: Female
• Patient Weight: 667 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White