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

Model Number 410322-05

Device Problems Device Displays Incorrect Message (2591); Mechanical Jam (2983)

Patient Problems Failure to Anastomose (1028); Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 06/08/2015

Event Type  Injury  

Event Description

It was reported that during a da vinci pancreatectomy procedure, the endowrist one vessel sealer instrument jammed and did not seal all the way, and the patient began to bleed.According to the initial reporter, a system error code 32001 had occurred during the event.A system error code 32001 occurs when the system detects that the blade of the endowrist one vessel sealer instrument cannot be retracted and may be exposed.On (b)(6) 2015 and (b)(6), intuitive surgical, inc.(isi) contacted the surgeon and obtained the following information regarding the reported event: the main issue was that the endowrist one vessel sealer instrument did not adequately seal a 4mm vessel.The surgeon reviewed a video of the surgical procedure and saw evidence that the instrument was attempting to seal tissue that was not excessively large in size.As a result, the surgeon made the decision to convert the surgical procedure to open surgery in order to control the bleeding.The event occurred towards the end of the da vinci surgical procedure.After completion of the da vinci pancreatectomy procedure, the surgeon had already planned to perform open surgery to perform reconstruction.The resection portion of the surgical procedure was to be completed with the da vinci surgical system.However, due to the bleeding, the surgeon indicated that she had to open sooner than planned and the incision was consequently almost double what it could have been.When a surgical staff member removed the endowrist one vessel sealer instrument, it was observed that the instrument's blade was exposed.Initially, 700-800 ml of blood was lost.Additional blood was lost during the process of trying to locate and secure the bleeding vessel.A surgical staff member indicated that the estimated blood loss of the surgical procedure was 1500 ml.On (b)(6) 2015 and (b)(4)2015, isi contacted the isi clinical sales representative (csr) who was present during the surgical procedure.According to the csr, the surgeon was able to use the endowrist one vessel sealer instrument for a significant period of time during the surgical procedure without any issues and up and until the event occurred.The csr indicated that the surgeon attempted to grab and seal a tissue bundle that appeared to be fat and omentum.During the process of sealing, bleeding was observed.Soon after, the system error code 32001 appeared.The csr was unsure if the surgeon attempted to cut with the instrument after attempting to seal the tissue and before the error code 32001 appeared.The case was converted to open surgery.On post-op day 1, the surgeon informed the patient that the surgical procedure was completed and the patient was doing fine.

Manufacturer Narrative

Isi has received the instrument involved with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint that the instrument jammed and did not seal.The instrument was installed on an in-house system and a self-check test passed.The instrument also passed a cut test, grip force test, and continuity testing.A paper towel was placed between the instrument's grips and smoke was observed coming from grips when the pedal was activated.The instrument failed a gap gage test which can cause the seal function to not work properly.Isi has reviewed the site's system logs with a procedure date of (b)(6) 2015.The system logs reveal that the surgical staff encountered a single system error code 32003 during the surgical procedure.A system error code 32003 signifies that the endowrist one vessel sealer instrument was not able to drive the cutting blade across the full range of travel during a cut command.This can be caused by a dirty instrument or during attempts to cut very thick and/or unsealed tissue.In addition, a single system error code 32001 occurred approximately an hour later.The instrument was used for approximately 1 hour and 34 minutes.No other related system errors were found to have occurred during the surgical procedure.Isi has attempted to contact the site to obtain additional information concerning the reported event; however, no additional information has been provided as of the date of this report.A follow-up mdr will be submitted if additional information is received.This complaint is being reported due to the following conclusion: during a da vinci pancreatectomy procedure, the endowrist one vessel sealer instrument allegedly did not seal adequately and the patient sustained blood loss of approximately 1500 ml.In addition, the instrument was returned to isi, evaluated, and failed a gap gage test.

Manufacturer Narrative

In relation to the reported event, intuitive surgical, inc.(isi) received fda (b)(4) with the following event description: during the robotic surgery a recoverable fault occurred with the robot.Fault code = 32001 or 'vessel sealer jammed'.This fault caused the vessel to not be sealed properly and the patient has an estimated blood loss of 1500 ml very quickly.What was the original intended procedure? robotic assisted open pylorus preserving whipple device usage problem: device malfunction - that is the device did not do what it was supposed to do.Based on the additional and current information provided, this complaint will remain reportable due to the following conclusion: during a da vinci pancreatectomy procedure, the endowrist one vessel sealer instrument allegedly did not seal adequately and the patient sustained blood loss of approximately 1500 ml.In addition, the instrument was returned to isi, evaluated, and failed a gap gage test.

• Brand Name: ENDOWRIST ONE VESSEL SEALER INSTRUMENT
• Type of Device: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA 94086
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA 94086
• MDR Report Key: 4906273
• MDR Text Key: 6831438
• Report Number: 2955842-2015-00985
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K110639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410322-05
• Device Lot Number: M11150320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention