MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; STAPLER 30

Model Number 470430-08

Device Problem Mechanical Problem (1384)

Patient Problem Blood Loss (2597)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the stapler 30 instrument (pn: 470430-08 || ln: t10190318 0045) involved with this complaint and completed the device evaluation.Failure analysis (fa) concluded that the reported failure was not confirmed or replicated.The customer reported issue was not confirmed nor replicated.Functional test failed due to a jammed mechanism, user error, and failed initialization.Visual inspection showed no hardware damage at the wrist.The instrument was found to have loose grip cables.Cause of loose cables is attributed to a component failure, although it is not clear which component failed in order to cause the cables to come loose.Loose grip cables would not prompt a message to the user indicating that the srk may be required.Site history review was conducted on 3-nov-2020 and found an additional complaint related to this event for a recoverable error.No image or video clip for either reported event was submitted for review.System error log review was conducted on 3-nov-2020 for a procedure on (b)(6) 2020 on system sk0874.An e-stop event was recorded yet there were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality.A review of the instrument logs was performed on 3-nov-2020.Endowrist stapler 30 instrument pn: 470430-08 || ln: t10190318 0045 was last used in this procedure and it had 49 of 50 remaining uses.Two white reloads pn: 48630w were also recorded.All other reusable instruments used in the case were used in subsequent procedures and a site review shows no complaint filed against the instruments.An isi advanced failure analysis (afa) engineer review of the stapler instrument log involved with this event was requested, and findings were as follows: logs show that the endowrist stapler 30 instrument was installed two times, both with white reloads.Upon the first install, the instrument successfully clamped/fired/unclamped.Upon the second install, the instrument completed initialization but no clamps were attempted and the instrument was in following mode based on the last dsp log event.An emergency stop (e-stop) event was recorded and the system detected a stapler release kit (srk) use on this instrument roughly 5 minutes after the last dsp log event.There is nothing in the logs that explains why the customer would have received the message to use the srk.Further, there was no indication of a ¿partial tool off¿ based on the log review.While there was no allegation that the blood loss occurred due to use of an isi product or that an isi product caused or contributed to the bleeding, the described blood loss and subsequent blood transfusion meets the criteria of a reportable event.Additionally, the root cause of the intra-operative bleeding cannot be determined.

Event Description

It was initially reported that during a da vinci-assisted nephrectomy, an endowrist stapler 30 instrument successfully fired once.Upon the second attempt to use the endowrist stapler 30 instrument, it passed through the trocar, seated in the carriage, and the surgeon asked for it to be removed for an unknown reason.As the bedside assistant attempted to remove the instrument from the system arm, an error presented: "emergency release kit may be required".The procedure converted to open due to ¿other issues." on 2-nov-2020, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: it was reported that during a da vinci-assisted nephrectomy, when the surgeon was working with the left renal vein, an endowrist stapler 30 instrument successfully fired once, with a white reload, but prior to the second attempt to use the endowrist stapler 30 instrument, it passed through the trocar, seated in the carriage, and the surgeon asked for it to be removed for an unknown reason.As the bedside assistant attempted to remove the instrument from the system arm, an error presented: "emergency release kit may be required".The instrument was removed successfully with the use of an ¿emergency release kit¿ but the procedure converted to open due to ¿other issues¿, ¿clinical¿ reasons, due to patient anatomy and bleeding not associated with the stapler issue.There was no allegation that the blood loss occurred due to use of an isi product or that an isi product caused or contributed to the bleeding.There was no report of instrument clamping issue.There was no report of staple line issue.A vascular surgeon was called in for consultation of the adrenal artery/artery branch.There was 800ml of estimated blood loss for which there was, ¿one unit prbc¿ of blood transfused.The procedure completed via open surgery with no report of patient harm or injury.The patient¿s current status was that they were discharged home.

Manufacturer Narrative

Upon further review and investigation of the reported event, intuitive surgical, inc.(isi) has determined that the adverse event reported on the initial mdr (mfr.Report #2955842-2020-11257) was already submitted previously on 29-oct-2020 via mfr.Report #2955842-2020-11141.On 16-dec-2020, isi contacted the isi clinical sales manager and verified that the surgeon had performed only one da vinci-assisted nephrectomy procedure on (b)(6) 2020 that resulted with a conversion to open surgery for clinical reasons unrelated to any issues with a da vinci product.Therefore, isi has determined that the adverse event reported via mfr.Report #2955842-2020-11257 (submitted 25-nov-2020) is a duplicate incident to the adverse event reported via mfr.Report #2955842-2020-11141.

• Brand Name: ENDOWRIST
• Type of Device: STAPLER 30
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10897117
• MDR Text Key: 219363190
• Report Number: 2955842-2020-11257
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112700
• UDI-Public: (01)00886874112700(10)T10190318
• Combination Product (y/n): N
• PMA/PMN Number: K152421
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 470430-08
• Device Catalogue Number: 470430
• Device Lot Number: T10190318 0045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Date Manufacturer Received: 12/16/2020
• 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
• Patient Age: 66 YR
• Patient Weight: 77