MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 45

Model Number	470298-14
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigation did not confirmed the reported failure.Per failure analysis (fa): the functional testing of the device in an attempt to replicate the report complaint is not possible due to the returned condition of the device.A review of the logs did not show any firing failures.Additional observations not reported by site that is not related to the customer reported complaint: the instrument was found to have an unclamp failure based on log reviewed.The root cause is not determinable/applicable.Unclamp failure log review details: procedure = abdominoperineal resection # unclamp failures = none reload color installed during failure = blue install number(s) of instrument during unclamp failure = 3 # of firings by inst prior to unclamp failure = 1 unclamp failure completion pct.= 6.85 clamp history of inst.In procedure with unclamp failure = 1.The instrument was found to have fire homing failures based on log review.The root cause is not determinable/applicable.The instrument was found to have a derailed grip cable.Root cause of this failure is attributed to a component failure.The instrument was found to have a broken pivot pin.Root cause of this failure is attributed to user.In addition to above analysis: the instrument was found to also have unclamping failure during in-house testing.The instrument was found to have a dislocated clamp cardan.Root cause of this failure is attributed to user.The instrument was found to have the yaw plate broken.Yaw plate web was bent outwards towards both the clamp and fire cardan.Root cause of the failure is attributed to user.Related & duplicate complaints identification: as of 04/30/2021 a review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event.No image/video investigation required as no image or video clip for the reported event was submitted for review.Advanced technical review (results): system log investigation: a review of the fire homing failures for the stapler associated with this event has been performed by an intuitive surgical, inc.(isi).The following additional information was provided: fire homing failures are a type of initialization failure.As part of initialization, the system tests the clamp and fire mechanisms.For the fire mechanism test, the fire cardan is rotated a fraction of a turn forwards and backwards, and the fire torque needs to be within certain limits.If the torque (or position) is out of range, the system fails the initialization, and will not allow the instrument to be inserted past the cannula tip.It's not common that something in the instrument causes fire homing failures, but we've seen that if the reload shuttle is not in the expected position when the reload is installed into the jaws, that can cause fire homing to fail.One way we've seen this fail is if the user manually rotates the triangular pin at the back of the reload (which can move the shuttle forward, in which case the fire torque can be below the lower limit, or move the shuttle backwards, which can jam the shuttle against the cartridge, and cause the fire torque to be above the upper limit).This complaint is being reclassified as a reportable event due to the following conclusion: there was an allegation that the device's grips/jaws failed to open after they had initially worked, which was also confirmed via failure analysis.Based on the information provided, there was no report from the customer that the device became stuck shut on tissue.While there was no report of harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.It was reported that during a da vinci-assisted surgical procedure, endowrist stapler 45 had firing issue.The procedure was completed with no reported injury.The fa confirmed that the functional testing of the device in an attempt to replicate the report complaint is not possible due to the returned condition of the device.At this time, complaint investigation has been completed and this record will be closed.If additional information related to this complaint is obtained, the record will be reopened for further evaluation.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, endowrist stapler 45 had firing issue.The procedure was completed with no reported 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.

• Brand Name: ENDOWRIST
• Common Device Name: STAPLER 45
• 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: 17016022
• Report Number: 2955842-2023-15122
• Device Sequence Number: 6976053
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T10200528
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K140553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

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: 470298-14
• Device Catalogue Number: 470298
• Device Lot Number: T10200528 0037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2020
• 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