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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST VESSEL SEALER EXTEND

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INTUITIVE SURGICAL, INC ENDOWRIST VESSEL SEALER EXTEND Back to Search Results
Model Number 480422-01
Device Problems Retraction Problem (1536); Difficult to Open or Close (2921)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 05/06/2021
Event Type  malfunction  
Manufacturer Narrative
Intuitive has received the vessel sealer extend (vse) associated with this complaint and completed investigations. Failure analysis investigations confirmed but did not replicate the customer reported complaint "error message that said the blade was exposed. The instrument was found to have dislodged blade failure based on log review. No conductor wire damage or snake wrist damage was found. There was significant bio debris found at the instrument tip. The root cause of dislodged instrument blades is typically attributed to mishandling/misuse. The instrument was placed and driven on an in-house system. The instrument passed the self-test. The instrument moved intuitively with full range of motion in all directions. The grips opened and closed properly. The instrument passed the knife slot test. No damage found to the blade and knife cable. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. A log review showed that vse with lot number m 91201215-0227 was used on a low anterior resection procedure on system (b)(4) on 06-may-2021. A review of the system logs was performed and it was confirmed that a "vessel sealer blade cannot retract¿ error message appeared. Although none of the reusable instruments were reused in subsequent procedures, a site review shows no complaint filed against any of the instruments. The system logs were also reviewed by a advanced failure analysis (afa) engineer and the following information was obtained: vse *-0227 was the first vessel sealer used, and *-0214 was the backup. Approximately 20 mins after vse usage started, there was a ¿jaw angle open¿ event, which indicates the jaws were detected to be too far open to allow safe cutting/not expose the blade. This is most likely due to the user attempting to cut with too much tissue between the jaws. After the ¿jaw angle open¿, the user activated one energy once more, then attempted to cut again. This next cut failed, and the instrument then went through the recovery sequence. The last event recorded was ¿blade recovery¿ which suggests the instrument was able to recover the blade within the jaws. Failed cuts and exposed blades are most likely due to the user. Examples; attempting to cut through too much tissue, cutting through a hard object (clip/staple/etc. ), or failure to keep the jaws of the instrument clean. The user has to hit the ¿arm swap¿ button to restore instrument control after recovery. We cannot verify via the logs if this pedal was pressed, but this is likely the reason the ¿jaws would not open¿. If we receive the instrument for rma, failure analysis will be able to confirm if the instrument jaws are functional. If the arm swap pedal could not open the instrument, they could have used the grip release slider barring some mechanical failure of the instruments grip mechanism (which we won't be able to confirm if/until the instrument is returned for fa). However, to use grip release they would have had to press the e-stop first- i do not have record of the e-stop being pressed in the procedure. " no image or video clip for the reported event was submitted for review. This complaint is reportable due to the following: the vse is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. When functioning properly, the instrument has both visual (tissue effect) and audio (tones from the generator) cues that provide feedback to the user that it is operating as intended. During a da vinci-assisted low anterior resection procedure, there was a ¿blade exposed¿ error message and the jaws of the vse could not unclamp. The instrument was clamped on the ima, causing bleeding amounting to 100 ml. The site tried using the emergency grip slider without putting the system in a faulted state, and it did not work. The surgeon used a laparoscopic ligasure instrument to dissect the vse instrument off the ima and completed the procedure robotically using a backup instrument. Failure analysis of the instrument was completed which confirmed the exposed blade error from the logs but did not replicate the problem. The instrument moved with full range of motion, the grips opened and close properly. There was significant biodebris seen at the instrument tips. Root cause of dislodged blade is typically due to mishandling/misuse. The logs were reviewed by an isi afa engineer and it was found that there was a ¿jaw angle open¿ event, which indicates the jaws were detected to be too far open to allow safe cutting/not expose the blade. This is most likely due to the user attempting to cut with too much tissue between the jaws. The user attempted to seal and cut again and failed, causing the instrument to go into recovery sequence. The last event recorded was ¿blade recovery¿ which suggests the instrument was able to recover the blade within the jaws. Failed cuts and exposed blades are most likely due to the mishandling. From the logs, it was noted that the customer did not press the e-stop button to utilize the emergency grip release. The following warning is found in the vessel sealer extend user manual: warning: do not perform grip release on a non-faulted system without first pressing the emergency stop button. Failure to observe this warning may result in unintended instrument motion or damage to the grip release mechanism. Thus, the inability to release the instrument using the grip release slider was likely due to failure of the customer to press the e-stop button prior to using the safety feature. Failure analysis of the instrument revealed that the jaws could open and close properly. The bleeding that occurred when the "blade exposed " error appeared was likely due to insufficient seal of the vessel sealer extend, and thus, is a reportable malfunction. Although it was reported that the patient experienced bleeding, there is no information provided to suggest that the patient sustained a serious injury. There is no information provided to indicate that the bleeding was life-threatening, required medical intervention to prevent permanent impairment, or resulted with disability or permanent impairment. In addition, there is no indication that the patient required hospitalization due to the bleeding. The additional removal of blood vessel to free the instrument did not necessitate additional functional tissue removal or cause permanent function impairment. If additional information becomes available, a follow-up mdr will be submitted.
 
Event Description
It was reported that during a da vinci-assisted low anterior resection procedure, there was an error message that said that the blade on the vessel sealer extend (vse) was exposed and the jaws would not open. The instrument stopped on a vessel, causing minimal blood loss on the patient. The surgeon used a laparoscopic ligature to help control the bleeding. The surgeon believes the vse caused the bleed as the bleeding occurred when the error message appeared. The procedure was completed robotically. Intuitive surgical, inc. (isi) followed up with isi clinical sales representative (csr) who was not present during the procedure but obtained the following information from the surgeon: the issue occurred with the first vessel sealer extend (vse) instrument. The vse was working fine for a while before the issue occurred. The surgeon was trying to cut and seal the inferior mesenteric artery (ima). The sealing sequence occurred with no issues. There was continuous tone when the pedal was pressed and fast audible beeps when the sealing cycle was complete. The error message occurred during the cutting phase. The surgeon pressed the arm swap pedal, but the vse could not unclamp from the ima. The surgeon then took control of the other 2 instruments (fenestrated bipolar forceps and tip up fenestrated grasper) to clamp the ima and used a third party ligasure instrument (via the laparoscopic port) to dissect the vessel sealer off the ima. Only a small amount of tissue had to be dissected out and there was no functional impact from the loss of the dissected tissue. A backup vse was then installed, and the procedure was completed as planned with no more issues. The patient is doing well post-operatively with no post-operative complications. The amount of blood loss was 100 ml and the patient was not transfused with blood or admitted to a higher level of care. The target tissue diameter was less than 7nmm, not under any tension, there was no calcification of blood vessel, no previous exposure of tissue to chemotherapy and radiotherapy, no biodebris was in the jaws of the instrument and the jaws were not immersed in liquid. When asked about what the surgeon did when he received the "jaw angle open" message, the csr said that he did not know as the surgeon did not mention that to him. Demographic information, previous medical history and relevant investigation was asked but not provided. On 11-may-2021, isi followed up with the robotic coordinator, who spoke to the scrub tech, and obtained the following information: the instrument was inspected before use and there was no damage seen. The issue occurred during sealing and cutting of the ima, about 1 hour after use. The surgeon received the continuous long tone during sealing and a seal complete audible feedback. Tissue effect was seen during the sealing process. There was a "blade exposed" message and the instrument jaws would not open and could not be removed from tissue. The site tried using the emergency grip slider, but the instrument jaws still would not open. The tissue was removed using a laparoscope ligasure to resect tissue that was attached to the vse. The surgeon had to resect additional vessel tissue although the resection did not incur permanent functional impairment to the patient. There was bleeding from the ima due to the use of the vse, but no blood transfusion was given. The target tissue was less than 7 mm in diameter, there was no evidence of calcification, no previous exposure of the tissue to radiotherapy and chemotherapy, the jaws were not immersed in liquid and there was no biodebris on the instrument. The surgeon believes the issue was due to a defective instrument. There are no images/video available for review. Demographic info/medical illness and relevant investigation information were not available. On 13-may-2021, isi followed up with the robotic coordinator, who spoke to the scrub tech, and obtained the following information: the amount of blood loss was 100 ml. The staff did not press the e-stop button prior to using the emergency grip slider. It is unknown whether there was an allegation of insufficient sealing.
 
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Brand NameENDOWRIST
Type of DeviceVESSEL SEALER EXTEND
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 Key11906751
MDR Text Key267745011
Report Number2955842-2021-10591
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173337
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 05/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number480422-01
Device Catalogue Number480422
Device Lot NumberM91201215 0227
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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