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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 Problem Device Issue (2379)
Patient Problem Failure to Anastomose (1028)
Event Date 04/02/2018
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, isi has not determined the root cause for the alleged post-operative complication experienced by the patient. If additional information is received a follow-up mdr will be submitted to the fda. The site¿s system logs with a procedure date of (b)(6) 2018 were reviewed. The system logs reveal that four stapler firings were completed using three green stapler 45 reloads and one white stapler 45 reload. However, during the third stapler firing using a green reload, there were 24 incomplete clamps in 25 attempts. The stapler 45 user manual instructs the following: "if clamping does not complete on the second attempt" to "reposition the stapler: tap the associated blue pedal once to unclamp. Reposition the stapler 45 to either grasp thinner tissue or to reduce the amount of tissue in the jaws. Then press and hold the associated blue pedal to clamp. " based on the information provided at this time, this complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted lar procedure, the patient experienced an anastomotic leak. The surgeon alleged that the post-operative leak might have been caused by the stapler 45 instrument. However, at this time, the root cause of the post-operative complication is unknown.
 
Event Description
It was reported that after undergoing a da vinci-assisted low anterior resection (lar) procedure, the patient experienced an anastomotic leak. The surgeon claimed that a da vinci stapler instrument might have caused the post-operative complication. On 30-apr-2018, intuitive surgical inc. (isi) contacted the isi clinical sales representative (csr) and obtained the following information regarding the reported event: the csr was present during the case. He did not know if the procedure was recorded on video. At one point, the surgeon attempted multiple clamps that reached 97-99% but would not reach 100%. The surgeon kept "revving" and re-clamping the stapler instrument until finally achieving 100%. The csr described the patient as being "big" in terms of height. There were no reports of tissue bunching or tissue tension when firing the stapler instrument. He did not believe the rectum tissue was abnormally thick. The procedure was completed robotically. A circular stapler instrument was used during the case. On an unspecified date post-operatively, the patient was found to have an anastomotic leak where the stapler 45 instrument was used. According to the csr, the surgeon believes the tissue might have been damaged due to the multiple attempts to clamp on the tissue. The patient underwent another surgical procedure to repair the anastomotic leak. He did not know the current status of the patient.
 
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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 road
sunnyvale CA 94086
Manufacturer Contact
tabitha reed
950 kifer road
sunnyvale, CA 94086
4085232100
MDR Report Key7487244
MDR Text Key107378731
Report Number2955842-2018-10177
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 company representative
Reporter Occupation
Type of Report Initial
Report Date 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number470298-11
Device Lot NumberT10180125 0002
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2018
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: 05/04/2018 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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