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

Model Number 470298-14

Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the stapler 45 instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.The instrument experienced an unclamp failure.A review of the error logs showed that this instrument was used during a procedure on (b)(6) 2020 with system (b)(4) and failed due to an ¿unclamping failure,¿ leading to the grips to not open properly.Failure analysis found the primary failure of an unclamp failure to be related to the customer reported complaint.The instrument was found with a broken grip cable at the wrist.Intuitive motion was not being experienced upon manual input of the disk knobs.Any potential fragments would have been retained by the stapler sheath.Failure analysis found the additional failure of a broken grip cable to be related to the customer reported complaint.The instrument was also found with a broken pivot pin.The pivot pin appeared to be sheared, allowing the wrist to jut out further than normal with applied force when articulated.No material appeared to be missing.Any potential fragments would have been retained by the stapler sheath.The known common cause of this failure is mishandling/misuse.Failure analysis found the additional failure of a broken pivot pin to not be related to the customer reported complaint.Unclamp failure log review details: # unclamp failures = 1, reload color installed during failure = blue, # of firings by instrument prior to unclamp failure = none, unclamp failure completion pct.= 45.A review of the logs showed the stapler 45 instrument (part #470298-14 / lot #t10190718-0053) was last used on (b)(6) 2020 during this reported procedure with system (b)(4).The logs confirmed the stapler 45 instrument fired 0 stapler 45 reloads.The stapler 45 instrument has 50 allotted uses and 46 uses remaining.In addition, a review of the site's complaint history identified no other complaints related to the stapler 45 instrument.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: the stapler 45 instrument was unable to unclamp or incurred a failure mode that is known to prevent unclamping of the instrument jaws.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 Description

It was reported that during a da vinci-assisted surgical procedure, the stapler 45 instrument was frozen.The customer replaced the stapler 45 instrument with a back-up instrument of the same kind and completed the procedure.Intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: according to the reporter, the instrument was not used on the patient.There was no patient harm, injury or adverse outcome.

• Brand Name: ENDOWRIST
• Type of Device: 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: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11299360
• MDR Text Key: 246552425
• Report Number: 2955842-2021-10121
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T10190718
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470298-14
• Device Catalogue Number: 470298
• Device Lot Number: T10190718-0053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Date Manufacturer Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1