MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; VESSEL SEALER

Model Number 410322-05

Device Problems Failure to Deliver Energy (1211); Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the part involved with this complaint and completed the device evaluation.Failure analysis investigation did not replicate nor confirm the reported complaint of ¿insufficient seal.¿ the vessel sealer instrument was found to have a dislodged blade.The blade was exposed out of the blade garage 0.13 in.The blade was manually retracted, the instrument was installed on a system, and the instrument passed the self-test.The instrument also passed the cut test and energy delivery test.The grip force test resulted in the following measurements: straight 7.23 lbs, pitch 7.20 lbs, and yaw 7.34 lbs.There was no damage found to the conductor wire or snake wrist and no bio debris found at the instrument tip.A review of the logs showed 3 blade exposed failures.The generator used with the vessel sealer instrument and da vinci system is designed to provide a successful confirmation signal to indicate seal completion.However, it is unknown if there was a successful confirmation signal following the reported sealing cycle attempt.This complaint is being reported due to the following conclusion: it was alleged that during a da vinci-assisted surgical procedure, the vessel sealer instrument did not seal.While there was no patient harm, adverse outcome or injury reported, recurrence of the reported malfunction could cause or contribute to an adverse event.It is unknown what caused the sealing issue.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the vessel sealer instrument stopped working after a couple of uses and stopped the whole system from working.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) made multiple follow up attempts to obtain additional information, however, no further details have been received as of date of this report.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Additional information can be found in the following sections: g4, h1, h2.4310- intuitive surgical, inc.(isi) followed up on 3/6/2020 and obtained the following additional information: the vessel sealer instrument worked initially, but stopped working halfway through the required time of use.During the sealing cycle, tissue effect was observed on the prostate pedicles (right side).When the issue occurred, the light on the system arm where the vessel sealer instrument was connected turned to amber and alarmed.The sealing cycle did not complete with the fast audible tones as expected.A review of the instrument and system logs was conducted to obtain the following information.The instrument had 0 lives left and was not used in subsequent procedures.The following instruments were used during the procedure: prograsp forceps, monopolar curved scissors, precise bipolar forceps, large needle driver, cadiere forceps, and another vessel sealer.There were multiple blade exposed error messages reported by the system.Based on the information obtained from follow-up, this complaint is being reclassified as a non-reportable event due to the following conclusion: the endowrist vessel sealer instrument is designed to generate system error messages when the da vinci surgical system detects a problem during sealing.The generator emits audible tones during the sealing cycle and when the sealing cycle is complete.In this case, a continuous tone was heard while the pedal was pressed.The vessel sealer stopped functioning halfway through the sealing sequence at which point an error presented, and a continuous audible alarm was emitted.The seal cycle did not complete with fast audible tones.The instrument behaved as intended after the system detected a potential problem.

• Brand Name: ENDOWRIST
• Type of Device: VESSEL SEALER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 9772553
• MDR Text Key: 191753510
• Report Number: 2955842-2020-10154
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410322-05
• Device Lot Number: M11190801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES