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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. ENDOWRIST ONE VESSEL SEALER ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

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INTUITIVE SURGICAL,INC. ENDOWRIST ONE VESSEL SEALER ENDOSCOPIC ELECTROSURGICAL INSTRUMENT Back to Search Results
Model Number 410322-05
Device Problems Use of Device Problem (1670); Device Dislodged or Dislocated (2923)
Patient Problems Tissue Damage (2104); Blood Loss (2597)
Event Date 05/26/2017
Event Type  Injury  
Manufacturer Narrative
Isi has received the instrument involved with this complaint and completed the device evaluation. Failure analysis investigation found that the blade was 0. 118 outside of the garage. There was no bio-debris observed at the wrist. The instrument's blade was retracted and the instrument was installed on an in-house system. The instrument passed self check testing. It was concluded that the blade was outside of garage due to mishandling/misuse. Failure analysis investigations also found that the instrument's snake wrist was dislodged. This was due to mishandling and misuse. Review of the instrument's logs found that several blade jams and homing failures had occurred. Intuitive surgical, inc. (isi) has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to the reported event. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the patient's tissue got stuck to the jaws of the endowrist one vessel sealer, thus causing a tear to the patient's tissue and subsequent bleeding. While isi's investigation found that the instrument exhibited damage due to mishandling and misuse, it is unknown what caused the patient's tissue to stick to the instrument and tear the patient's tissue.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, after the endowrist one vessel sealer instrument was clamped on the patient's tissue, the patient experienced bleeding. The surgeon was able to control the bleeding experienced by the patient. The surgeon made the decision to complete the case without the use of the endowrist one vessel sealer instrument. On 06-15-2017, intuitive surgical inc. (isi) contacted the site's surgical service coordinator regarding the reported event. According to the surgical service coordinator, the endowrist one vessel sealer instrument was used during a da vinci-assisted hysterectomy procedure. After sealing thin peritoneal tissue located in the area of the bladder flap, when the surgeon opened the jaws of the endowrist one vessel sealer instrument it was observed that the patient's tissue was sticking to the jaws of the instrument, thus causing a tear and subsequent bleeding. The surgical service coordinator indicated that the patient did not experience copious bleeding and the bleeding was controlled with an unspecified bipolar instrument. The surgical service coordinator indicated that it is unknown what caused the patient's tissue to stick to the jaws of the endowrist one vessel sealer instrument. There was no report of any presence of excessive bio-debris in the jaws of the instrument and during the instrument's sealing cycle the audible tones were generated and the end of the sealing cycle tones were also generated. No error messages or error codes were reported to have occurred. According to surgical service coordinator, the planned surgical procedure was completed with the da vinci surgical system. The patient did not require an intra-operative blood transfusion and there was no report to her that the patient required a post-operative blood transfusion as a result of the bleeding.
 
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Brand NameENDOWRIST ONE VESSEL SEALER
Type of DeviceENDOSCOPIC ELECTROSURGICAL INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL,INC.
sunnyvale CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC.
950 kifer rd.
sunnyvale CA
Manufacturer Contact
tabitha reed
950 kifer rd.
sunnyvale, CA 
4085232420
MDR Report Key6657245
MDR Text Key78078792
Report Number2955842-2017-00382
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110639
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 05/26/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number410322-05
Device Lot NumberM10170302 971
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/21/2017 Patient Sequence Number: 1
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