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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST STAPLER 45 Back to Search Results
Model Number 470298-11
Device Problems Device Issue (2379); Difficult to Open or Close (2921)
Patient Problem Tissue Damage (2104)
Event Date 04/03/2018
Event Type  Injury  
Manufacturer Narrative
Isi has received the stapler 45 instrument involved with this complaint and completed investigations. Failure analysis investigations confirmed but could not replicate the customer reported complaint of a "partial fire. ¿ the stapler instrument was unable to be tested in-house due to the condition the device was returned in. The instrument was found to have a broken conductor wire, grip cable, and hypotube. It cannot be determined if the instrument damage occurred during or after the reported event. Due to the instrument damage and missing instrument components, an accurate assessment of what may have caused the alleged partial fire and subsequent unclamp failure was not possible. The csr provided photo images of the stapler 45 instrument involved with the reported event. The photo images show the instrument clamped down on tissue. However, the photo images do not provide any information to determine a root cause of the customer reported failure modes. The site¿s system logs with a procedure date of (b)(6) 2018 were reviewed. The system logs show a system error 22030 had occurred which is indicative of a stapler firing failure. Approximately 10 seconds after the partial fire occurred, another 22030 error occurred which signifies a stapler instrument unclamping failure. A couple of minutes later, the system logs reveal that the e-stop button was pressed which is likely when the surgical staff attempted to use the srk. Based on the information provided at this time, this complaint is being reported due to the following conclusion: during the da vinci-assisted sigmoid colectomy procedure, the stapler 45 instrument allegedly misfired and could not be unclamped from colon tissue. As a result, the surgeon had to remove more colon tissue than planned.
 
Event Description
It was reported that during the da vinci-assisted sigmoid colectomy procedure, the stapler 45 instrument allegedly misfired while clamped down on colon tissue. It was also alleged that the instrument could not be unclamped from the tissue even with the use of the emergency wrench or stapler release kit (srk). As a result, the surgeon had to remove more colon tissue than planned. On 04-apr-2018, intuitive surgical inc. (isi) contacted the site¿s coordinator, a nurse, for colorectal procedures and obtained the following information regarding the reported event: the nurse stated that she was not present during the procedure; however, she was informed of the incident. She stated that during the robotic procedure, the endowrist stapler 45 instrument was used with a green stapler 45 reload installed. During the surgeon¿s first attempt to staple the left colon with the stapler 45 instrument, an ¿incomplete fire¿ issue allegedly occurred and the surgeon could not unclamp the jaws of the instrument from colon tissue. The surgical staff attempted unsuccessfully to open the jaws of the instrument using a srk. The surgical staff then tried releasing the instrument from the sterile adapter. The surgical staff also tried turning the disks on the instrument¿s housing manually; however, the issue persisted. As a result, the surgeon used a hand-held laparoscopic stapler instrument to staple lower on the colon where the stapler 45 instrument allegedly misfired. Once the bowel resection was completed, the nurse stated that they manually released the stapler 45 instrument from the resected colon and the tissue was sent for pathology. The nurse confirmed that in order to retrieve the stapler 45 instrument, the surgeon had to transect more colon tissue than planned. According to the nurse, the procedure was completed with no other intra-operative complications reported. On 04-apr-2018, isi also contacted the csr and obtained the following additional information regarding the reported event: the csr confirmed the information provided by the nurse. However, the csr stated that the surgeon had to place another low pelvic incision in order to get the right angle to reach the colon using the hand-held laparoscopic stapler instrument. The csr explained that the surgeon could not use the hand-held stapler instrument through the laparoscopic assist port.
 
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Brand NameENDOWRIST
Type of DeviceSTAPLER 45
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer Contact
tabitha reed
950 kifer rd.
sunnyvale 
4085232100
MDR Report Key7466389
MDR Text Key106699880
Report Number2955842-2018-10159
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140553
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470298-11
Device Lot NumberS10170725 0024
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 04/26/2018 Patient Sequence Number: 1
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