Summary of MedSun Reports Describing Adverse Events With da Vinci Surgical Devices
MedSun: Newsletter #18, November 2007

Over the past 4 years, MedSun has received 26 adverse event reports associated with the da Vinci computer-assisted surgical device manufactured by Intuitive Surgical, Inc. The reports were submitted by 15 hospitals between January 2004 and May 2007. Twenty-three of these reports were selected as representative of the adverse events for inclusion below. The most commonly reported device problems were instrument breakage, particulate matter falling off instruments, and failure of the electromechanical arms to manipulate instruments. The patient injuries listed below were reported in 7 of these 26 reports.

•3 procedures converted to open surgery
•2 unexpected cardiopulmonary bypasses required
•1 additional incision site created
•1 tip of a needle left in patient

These MedSun reports contributed to FDA awareness of the device problems. FDA followup with the manufacturer resulted in the manufacturer’s voluntary recalls of the affected devices for their improvements.

[Note: The term "robotic" used in the reports is the common name for “computer-assisted” equipment. The latter term is preferred by FDA because the device is operated by a surgeon. The reports have been edited for clarity.]

1
Device Type: da Vinci, Monopolar Cautery,
Device Identifiers: Hot Shears (Mono Curved Scissors) Catalog# 400179; Lot# 0112061835
Event Description: A surgeon was performing a laparoscopic robotic-assisted myomectomy. During the procedure, a piece of the orange tube extension broke off the monopolar curved scissor. Another monopolar curved scissor was given to the surgeon to use, and the orange tube extension on that instrument broke into pieces. The silicone tip cover was not used with either of the monopolar curved scissors. Our initial thought was that the damage was caused when the electrosurgical unit was activated without the silicone tip cover. The Intuitive Surgical, Inc., engineer informed us that the tip cover adds support to the end of the tube extension. When the instrument is cutting, it puts additional stress on the end of the tube extension. The engineer also informed us of the importance of using the silicone tip cover to prevent alternate site burns. Staff who were trained by the company clearly understood that the silicone tip cover provided insulation to prevent burns, when used for cauterizing, but did not have any knowledge of the silicone tip cover’s support for the monopolar curved scissors. Our evaluation of the monopolar curved scissors is that the failure was based on human error and the design of the instrument. The monopolar curved scissors were returned to Intuitive Surgical, Inc., for evaluation. Our recommendation for future designs would be for the company to develop a better product that takes into consideration the possibility of failure.

2
Device Type: da Vinci S, Monopolar Cautery, Curved Scissors, Hot Shears (Mono Curved Scissors)
Device Identifiers: Catalog# 420179; Lot# 290101724, Other Device# Version 4
Event Description: The patient underwent a robotic-assisted total laparoscopic hysterectomy with bilateral salpingo-oophorectomy for fibroid tumors. During the procedure, one of the blades on the robotic scissors broke off.

3
Device Type: da Vinci S, Monopolar Cautery, Curved Scissors, Hot Shears (Mono Curved Scissors)
Device Identifiers: Catalog# 420179; Lot# 70806158
Event Description: During the procedure, some small, black particles were noted as debris from the da Vinci monopolar curved scissors. The wound was irrigated, and black particles were suctioned out by the surgeon.

4
Device Type: Ultrasonic Energy Instruments, Harmonic Curved Shears With Insert
Device Identifiers: Catalog# 400169-05; Lot# C6123
Event Description: The movable cutting tip of the harmonic curved shears broke during a robotic-assisted laparoscopic radical prostatectomy with preservation of the vascular bundles on both sides performed by the surgeon.

5
Device Type: da Vinci, Scissors, Curved
Device Identifiers: Catalog# P/N 400178; Lot# 140205187
Event Description: A patient was in the operating room for a robotic prostatectomy. The physician went to use the scissor instrument and noted that one of the blades was missing. Upon exploring the abdomen, the physician successfully retrieved the broken blade of the scissor. The event was reported to Intuitive Surgical, Inc., because the curved scissor is a new instrument in their inventory. The scissors that broke today had been used only once, the day before.

6
Device Type: da Vinci, Grasper, ProGrasp Forceps
Device Identifiers: Catalog# 400093
Event Description: At the end of a laparoscopic radical prostatectomy with robotic assistance, it was noted that the coating had rubbed off the ProGrasp instrument. The patient's abdomen was irrigated thoroughly, and no noted particles remained. Staff are aware that the coating can rub off from continual friction because of the positioning of the instrument. Because of draping, the field is hard to visualize. The da Vinci surgical team was made aware of the potential for this problem and will monitor the instruments while in use. Note that the ProGrasp instrument is tracked on number of uses. It was not documented as to how many times out of 10 this particular ProGrasp had been used at the time of this event.

7
Device Type: da Vinci, Grasper, ProGrasp Forceps
Device Identifiers: Catalog# 400093
Event Description: During the robotic-assisted dissection of the prostate, one of the grasping ProGrasp Forceps broke at the point where the specialized jaw end of the instrument is hinged to the shaft. There were three small fragments of black-colored material noted intraperitoneally, and these were retrieved uneventfully. This was the fifth use out of 10. The manufacturer was notified regarding this failure, and we are retaining the device in the event the manufacturer requests to evaluate it. We have not experienced any similar problems with this particular instrument.

8
Device Type: da Vinci, Grasper, ProGrasp Forcep
Device Identifiers: Lot# 1408061 05 Ver06
Event Description: During a procedure, the EndoWrist ProGrasp instrument broke while engaged and holding the fibroid attached to the patient's uterus. Laparoscopic observation revealed that one piece of the instrument had broken off. The piece was recovered laparoscopically and removed. As the instrument was being removed from the patient's abdominal cavity, additional pieces of the instrument broke off. The procedure was converted to an open procedure.

9
Device Type: da Vinci, Grasper, ProGrasp Forceps, 8mm
Device Identifiers: Lot# 1103051
Event Description: A patient was in the operating room undergoing a robotic laparoscopic hysterectomy when the tip of the ProGrasp broke while in the patient. It was noted that a small plastic piece was missing; it could not be determined, however, if the missing piece was in the patient, and it could not be detected by X-ray.

10
Device Type: da Vinci, Bipolar Cautery, Maryland Bipolar Forceps
Device Identifiers: Catalog# 420172
Event Description: While in a patient's abdomen, the Maryland bipolar forceps appeared to have shavings or particulate material on it. Whether these shavings entered the patient is unknown.

11
Device Type: da Vinci, Monopolar Cautery, Permanent Cautery Hook
Device Identifiers: Catalog# 4001833; Lot# 0706051-14 ver.01
Event Description: The instrument malfunctioned and was removed from the patient. Closer inspection showed that the working end of the instrument was frayed, and spiderweb cracks were noted on the shaft. Two or three pieces of plastic material were manually removed from the patient's abdomen by the surgeon, and more pieces were found inside the laparoscopic trocar.

12
Device Type: Monopolar Cautery, Permanent Cautery Hook, 7mm
Device Identifiers: Lot# 230T021/40 ver .02
Event Description: During a da Vinci assisted laparoscopic cholecystectomy, the tip of the da Vinci 7 mm hook cautery came apart. Three separate plastic pieces were identified and withdrawn from the surgical field.

13
Device Type: da Vinci, Monopolar Cautery, Permanent Cautery Spatula
Device Identifiers: Catalog# 400184; Lot# 91105107
Event Description: After the second robotic surgery of the day, the sterile processing staff determined that a wire was broken and a piece of the device was missing.

14
Device Type: da Vinci, Needle Holder, Needle Driver
Device Identifiers: Catalog# 400117; Lot# 131205130 Version 09
Event Description: A robotic 5 mm needle driver was being used to suture. The instrument was holding a 2/0 silk and was being used to tie a knot when one side of the needle driver tip broke off. The piece was easily visualized and retrieved.

15
Device Type: da Vinci, Needle
Device Identifiers: Lot# 0412061-018
Event Description: The patient was in the operating room suite undergoing a robotic-assisted laparoscopic radical prostatectomy. The large needle driver broke during the procedure, and a small piece of the tip was left in the patient, according to the surgeon.

16
Device Type: da Vinci
Event Description: The patient was to undergo laparoscopic lysis of adhesions and retropubic radical prostatectomy utilizing robotic assistance. At beginning of the procedure, there was a malfunction on the second robotic arm. One of the plastic wings used to tighten down the arm broke off while the surgeon was attaching the second arm to the cannula. The robotic sensors would not allow the tool to be used. At this point, a company representative was called, and alternatives were discussed. (This was not a repairable piece of the robot during this surgery.) The surgeon was able to get the second arm functional, and it seemed to work, but as soon as one tool was changed out for another, the arm became nonfunctional again. The robot was undocked, and all the ports were closed in the usual fashion. The patient was prepped again, redraped, and underwent an open radial prostatectomy. The day after the event, the service representative from Intuitive Surgical, Inc., came to the site and installed a new mount (broken cannula mount) on the patient-side manipulator 2 and tested the system, and the system passed all tests.

17
Device Type: da Vinci
Event Description: During a cardiac robotic surgical procedure using a da Vinci surgical system, the robot's third instrument arm (ARM4) stopped functioning. The surgeon removed the instrument from the affected arm and placed it on ARM1, after which the instrument tested okay. The surgeon then tried unsuccessfully to reattach the instrument to ARM4 three different times, as instructed by the manufacturer's clinical representative, who was present during this surgical procedure. The surgeon had to make another incision in the patient to attach an atrium retraction instrument to complete the procedure. The manufacturer’s representative finally placed ARM4 in the complete STOW position and redeployed the arm to a cold reboot status. After the reboot of ARM4, the system was then able to detect the instrument, and the surgeon completed the case without having to use the additional incision site and without further robotic system failure.

18
Device Type: da Vinci S
Event Description: A physician was performing a laparoscopic radical prostatectomy with robotic assistance when a fault occurred with one of the instrument arms. Despite several attempts at restarting the system, and in telephone contact with the company, the system fault could not be overridden, and the procedure could not go further in its current status. The robot was then moved away from the patient, and the procedure was converted to an open radical prostatectomy. Analysis of the device identified a "third arm fault." Error code 25504 was identified, which basically indicated there was a "mismatch" code, meaning that there is a problem with the arm’s lining up perfectly. Mismatch can occur for a variety of reasons, from part failure to a dirty sensor. It was determined that the patient-side manipulator (PSM) was suspect. The service representative ordered and installed a new PSM and tested the system; the system passed all tests. The removed part was sent to the home office for analysis.

19
Device Type: da Vinci, Reusable System Accessory, Cannula Holder, Twist-Lock
Device Identifiers: Catalog# 370946-02
Event Description: A surgeon was performing a robotic-assisted total abdominal hysterectomy/bilateral salpingo-oophorectomy, when he began having trouble with the robotic third arm. A surgery technician discovered that the cannula holder had broken.

20
Device Type: da Vinci
Event Description: During a procedure employing the robotic surgical system to treat atrial fibrillation via radiofrequency ablation of ectopic foci, intraoperative bleeding was experienced that required initiation of a cardiopulmonary bypass. The bleeding of the atrial wall was caused by the AtriCure ablation electrode (Isolator Transpolar pen), which had been unhooked from the robotic arm and was being manipulated manually. The cardiopulmonary bypass was initiated to rectify and complete the procedure. Secondary complications included a stroke and aortic dissection.

21
Device Type: da Vinci
Device Identifiers: Model# SS2000
Event Description: The event occurred during a robotic thymectomy. The surgeon was operating with the robot, and we lost power to the robot. We unplugged and replugged in the tower until it repowered. The robot was reactivated, and surgery continued. The sales representative discovered that a plug to the da Vinci robot had been changed and placed in one of the power strips, which caused too much power to be drawn. The light source was to have its own outlet. The Biomedical Department corrected the problem by getting us a new cord, which was replaced after the procedure.

22
Device Type: Robotic Laparoscope Holder
Event Description: When the Bovie is in use, the Aesop command conflicts with the microphone connected and microphone disconnected, making the Aesop inoperable. There were two such incidents. The Biomedical Department assessment is that there is a possible interference between Valleylab ESU units and the Aesop units. The recommendation is that the operating room staff use only a certain ESU. When using Aesop units, this particular ESU does not seem to cause the problem. All three Aesop units have had related issues. The Biomedical Department is also following up with the manufacturer to determine if their representatives are aware of the problem.

23
Device Type: da Vinci
Event Description: During a procedure to repair the mitral valve regurgitation using the da Vinci robotic surgical system, the aortic valve leaflet was perforated during placement of the cardioplegia catheter. This necessitated initiation of a cardiopulmonary bypass to repair the leaflet and complete the procedure. Upon removal from the bypass, the patient entered cardiogenic shock brought about by biventricular failure. Additionally, the patient went into renal failure. The patient remains hospitalized with partial recovery of left ventricular function.


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