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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST STAPLER 30 RELOAD WHITE Back to Search Results
Model Number 48630W-04
Device Problem Entrapment of Device (1212)
Patient Problem Tissue Damage (2104)
Event Date 03/02/2020
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, the cause of the reported operative complication is unknown at this time. If additional information is received, a follow-up mdr will be submitted. On 01-apr-2020, isi contacted the csr and requested to obtain a copy of the video recording from the site, and that the curved tip stapler 30 instrument and the white stapler 30 reload be returned to isi for evaluation. It was confirmed that the curved tip stapler 30 instrument and the white stapler 30 reload are with the hospital's risk management team. A site history review was executed and it was confirmed that with the exception of the curved tip stapler 30 instrument involved in this incident, all the other instruments were used in subsequent procedures. Isi has reviewed the site¿s system logs with a procedure date of (b)(6) 2020. No related system errors were found to have occurred during the surgical procedure. The following curved tip stapler 30 instrument part number: 470530 lot # t11180907 0053 was installed 4 times and fired 3 white stapler 30 reloads. There were no clamps or fires attempted during the first install. The subsequent three installs had firings completed per the logs with zero incomplete clamps. There were no issues in the logs that would explain the customer reported issue. This complaint is being reported due to the following conclusion: it was reported that during a da vinci-assisted pulmonary wedge resection procedure, the curved tip stapler 30 instrument allegedly failed to fully staple the pulmonary artery. The stapler instrument became stuck on tissue and could not be removed. The surgeon released the stuck tissue without any injury to the patient. The procedure was completed with a laparoscopic vascular stapler and a curved tip stapler 30 instrument with no further issues. Although there was no bleeding experienced, there was an arterial line inserted in anticipation of blood loss. This medical intervention was not a part of the planned surgical procedure.
 
Event Description
It was reported that during a da vinci-assisted pulmonary wedge resection surgical procedure, the surgeon was unable to remove the curved tip stapler 30 instrument from the patient¿s tissue. The surgeon was able to release the tissue with a laparoscopic scissor instrument in order to remove the curved tip stapler 30. The procedure was completed with no reported injury. On 09-mar-2020, intuitive surgical, inc. (isi) contacted the isi clinical sales representative (csr) and obtained the following additional information regarding the reported event: the curved tip stapler 30 clamped and fired successfully. When the surgeon unclamped the curved tip stapler 30, the anvil part of the instrument was stuck on tissue. The surgeon used a rolled up sponge and put it on a laparoscopic scissor instrument to push the curved tip stapler 30 away from the tissue. There was no bleeding and no harm to the patient. The procedure was completed robotically with no patient injury. It is unknown if the site will return the curved tip stapler 30 instrument for evaluation. On 26-mar-2020, isi received a medwatch stating the following: medwatch staff report: at the time of stapling the pulmonary artery, the stapler instrument misfired. When the jaws of the stapler instrument were opened, some staples remained attached to both the stapler instrument and the pulmonary artery, which did not allow for proper staple line/cutting of the pulmonary artery. It took meticulous work by the physician to figure out a way to remove the stapler instrument from the pulmonary artery without severing the artery and causing severe, potentially life-threatening bleeding. When the situation was noted, the anesthesiologist was called to the room to insert an arterial line and prepare for significant blood loss. It appeared the stapler instrument was on its next to last life when this event occurred. An additional stapler instrument and supplies had to be opened. Medwatch op report: the surgeon attempted to open the robotic vascular stapler instrument and it appeared that it was stuck to the wall of the ongoing pulmonary artery. The surgeon attempted carefully although was initially unsuccessful in freeing this off. The attending anesthesiologist was then called into the operating room and requested to place an arterial line immediately to be prepared to deal with catastrophic bleeding. While the anesthesiologist obtained the arterial line, the surgeon was able to meticulously free up the staple just from the arterial line without causing any injuries to the ongoing pulmonary artery. Next dissection performed on both the superior pulmonary vein as well as the truncus branch of the pulmonary artery. The superior pulmonary vein was divided 1st with the help of a handheld vascular stapler instrument. A new robotic vascular stapler instrument was then obtained and was used. The truncus branch was then divided with the help of this new robotic vascular stapler instrument. On 01-apr-2020 isi contacted the surgeon and obtained the following additional information: the surgeon stated that he had fired the curved tip stapler 30 instrument on the pulmonary artery with a white stapler 30 reload installed on it. There was no issue clamping, no system generated errors, and the instrument had clamped and fired. The jaws of the curved tip stapler 30 instrument unclamped with no issue; however, the surgeon stated that the ¿b shaped staples had not disengaged from the anvil fully, and some staples remained attached to both the instrument and the pulmonary artery. ¿ the surgeon¿s initial attempt to carefully release the tissue was unsuccessful. As a result, the attending anesthesiologist was then called into the operating room and requested to place an arterial line immediately to be prepared to deal with significant blood loss. This medical intervention was not a part of the planned surgical procedure. Eventually, the surgeon stated that he had used some rolled up sponge, put it on a laparoscopic scissor instrument and released the stuck tissue with no injury to the pulmonary artery. The surgeon confirmed the procedure was completed with a backup curved tip stapler 30 instrument. The surgeon confirmed the following: that there was no buttress material used, no issue with tissue integrity, no issue with incomplete clamps, and the patient was reported to have no injury and was recovering well. The surgeon is not sure what caused the staples to get stuck, stated he uses white stapler 30 reloads all the time and has not had any issues. There were no additional tests performed after the procedure, other than the usual relevant tests for lung cancer such as pet and ct scans. The surgeon did state there is a video recording of the procedure, and isi will be able to receive a copy.
 
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Brand NameENDOWRIST
Type of DeviceSTAPLER 30 RELOAD WHITE
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 95051
4085232100
MDR Report Key9914553
MDR Text Key194019072
Report Number2955842-2020-10259
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152421
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number48630W-04
Device Catalogue Number48630W
Device Lot NumberN/A
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 Received04/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/07/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/01/2020 Patient Sequence Number: 1
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