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

Model Number 470298-12

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has issued an rma to the customer requesting to have the stapler 45 instrument returned, however, isi has not received the rma to confirm/identify any reportable failure mode(s).No images or videos were shared for the event.A review of the instrument log was performed.Per the logs, the two stapler 45 instruments used in the case were: 470298-12; 10190211-0038 (total time used was 08:34) and 470298-14; t10190501-0041 (total time used was 00:39).Based on a review of the logs and complaint details, it was determined that the stapler 45 instrument (470298-12/t10190211 0038) was the stapler in question with the unclamping issue as it was used for 8 minutes and 34 seconds, while the second stapler 45 instrument (470298-14/t10190501 0041) is the stapler with the engagement issue as it was only used for 39 seconds.This complaint is being reported based on the following conclusion: the stapler 45 instrument failed to release from tissue when commanded by the user or system.Although no patient harm occurred, if this malfunction were to recur it could potentially cause or contribute to an adverse event.The product is not implantable.It is unknown if a report was submitted to the fda by the initial reporter.

Event Description

It was reported that during a da vinci-assisted sigmoid colectomy surgical procedure, the endowrist stapler 45 instrument would not unclamp after initial stapling.Customer used a second stapler, but that instrument was not recognized by the system arms.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the procedure was completed robotically, but the customer used a laparoscopic instrument.Additionally, the robotics coordinator, who was not in the case, was contacted.The robotics coordinator was informed that during a sigmoid colectomy procedure the surgeon had issues with two stapler 45 instruments.The first stapler fired successfully on colon tissue, but would not unclamp from the tissue.The assistant had to use the stapler release key to open the jaws, and removed the stapler.The customer does not know if the tissue was too thick or if there were any obstructions in the jaws of the stapler.Once the stapler was removed from the patient, the customer could not remove the reload from the stapler jaws.The second stapler 45 was used at this point, but this stapler failed to initialize and they could not use it.The customer elected to use a third party stapler for the rest of the case.The procedure was completed with no patient injury.The customer will rma both staplers.Information regarding patient demographics, relevant testing, and medical history was requested, however the coordinator was only able to report that the patient was a (b)(6) year old male that weighed (b)(6) kilos.

Manufacturer Narrative

4307- the stapler 45 instrument has been returned and evaluated by the failure analysis team.Failure analysis investigations confirmed but did not replicate the customer reported complaint of "45 endowrist would not unclamp." the instrument was returned with a stuck reload.Based on log review, the instrument was found to have an unclamping failure.However, the unclamping failure was not replicated during in-house testing.The instrument was placed on an in-house system and reworked in order to pass initialization to test for functionalities.The instrument clamped, fired, and unclamped successfully.The instrument was fired with a white stapler 45 reload and no malformed staples were observed.Additional findings not reported by the site were that the instrument was found to have a broken pivot pin.The root cause of this failure is attributed to mishandling.The instrument was also found to have a broken grip cable at the proximal end.This is likely due to the use of the stapler release kit (srk).The instrument was found to have corrosion on the bearings and camshaft.The root cause of this failure is attributed to mishandling.The stapler 45 instrument was transferred to advanced failure analysis (afa) for further inspection.Afa reported that the logs show that an unclamp failure occurred with a blue reload installed.Unclamp failure was preceded by an incomplete clamp, therefore the unclamp was user initiated.The logs do not show any emergency-stop press or srk usage detected on this instrument.However, the fact that the grip open cable was found broken at the proximal end suggested that srk use may have been attempted after the instrument was removed from the system, as this breakage is sometimes observed as a byproduct of srk use.Some signs of contact between the clamp cardan and pivot tube were observed on the pivot tube base.This potential contact between cardan and pivot tube occurs when the instrument is yawed fully to one side.The logs showed that the instrument was articulated at a high yaw angle when the unclamp failure occurred, however, this failure cannot be conclusively linked to the damage on the pivot tube.The cause of unclamp failure remains undetermined.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: STAPLER 45
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 11009419
• MDR Text Key: 221542363
• Report Number: 2955842-2020-11350
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T10190211
• Combination Product (y/n): N
• PMA/PMN Number: K140553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

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
• Device Operator: Health Professional
• Device Model Number: 470298-12
• Device Catalogue Number: 470298
• Device Lot Number: T10190211 0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES; DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Age: 50 YR
• Patient Weight: 50