MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DA VINCI; TIP COVER ACCESSORY

Model Number 400180-07

Device Problem Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Nerve Damage (1979)

Event Date 12/28/2017

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, isi has not determined the root cause for the alleged post-operative complications experienced by the patient.If additional information is received, a follow-up mdr will be submitted to the fda.Unable to perform system error log review with the lack of system and instrument detail on file at this time.Site history review was conducted on 3-nov-2020 and did not show any additional complaints related to this event.No image or video clip for the reported event was submitted for review.Based on the information provided at this time, this complaint is reportable due to the following: while fragments were allegedly retrieved, unintended fragment(s) falling into the patient may require surgical intervention.The plaintiff's attorney alleged system malfunction(s) yet the specific details were not provided.At this time, the cause(s) of the patient¿s alleged operative and/or post-operative complications are unknown and it is unknown what caused the breakage to occur.The system and/or instruments are unknown.According to the plaintiff¿s attorney, the surgeon allegedly ¿does not document the malfunctioning of the surgical robot, and checks the box for ¿complications: none.¿ however, the plaintiff¿s attorney alleged the da vinci malfunctioned during the procedure and, ¿an attempt to replace the malfunctioning portion resulted in parts of the robot breaking off and falling into the patient¿, reportedly prolonging the time under anesthesia.It was also reported that due the patient being placed in an awkward position led to alleged ¿nerve injuries in the back and legs¿.The patient¿s past medical history recorded in the legal document outlines ¿significant adhesions¿ and ¿large uterus¿.The plaintiff¿s attorney alleged that due to, ¿the large size of the uterus¿, the surgeon ¿chose to cut it into pieces so it could be removed vaginally¿.During this process, the surgeon ¿inadvertently lacerated¿ the patient¿s vulva and labia.The patient¿s current status is unknown.It is unknown if the initial reporter submitted a report to the fda.

Event Description

As part of a legal dispute intuitive surgical, inc.(isi) received information regarding a patient that underwent a da vinci-assisted hysterectomy on (b)(6) 2017.The legal document alleges that, as a result of the da vinci procedure, the patient suffered injuries and/or damages.The plaintiffs¿ attorney alleges the da vinci malfunctioned during the procedure and, ¿an attempt to replace the malfunctioning portion resulted in parts of the robot breaking off and falling into the patient¿, reportedly prolonging the time under anesthesia in an awkward position leading to alleged ¿nerve injuries in the back and legs¿.Isi's reps were reportedly contacted and, ¿once the robot was repaired and the broken pieces were retrieved¿, the surgeon documented, ¿leaving a portion of the uterus and cervix (which are supposed to be completely removed in a hysterectomy) behind because it was adhering to the bowel¿.Due to, ¿the large size of the uterus¿, the surgeon ¿chose to cut it into pieces so it could be removed vaginally¿.During this process, the surgeon ¿inadvertently lacerated¿ the patient¿s vulva and labia.The surgeon, ¿does not document the malfunctioning of the surgical robot, and checks the box for ¿complications: none.¿ it was alleged that the ¿pathology on the portion of the uterus that was removed documents the weight was 455 grams, measuring 20.5 x 20.0 x 5.0 centimeters.¿ the patient¿s status is currently unknown.The system and/or instruments are unknown.The patient¿s past medical history recorded in the legal document outlines ¿significant adhesions¿ and ¿large uterus¿.

Manufacturer Narrative

D15 - additional information related to this reported event was received.It was noted in the operative report that, after the bladder flap, ¿the scissors were noted to have a broken sheath on the end and it had appeared to be split at the plastic¿ and as the surgeon attempted to remove the instrument, ¿the sheath got caught on the trocar and it was unable to be pulled through¿ and ¿two pieces of the plastic on the sheath fell off into the peritoneal space¿.A ¿kelly clamp was used to place around the trocar to enlarge this space somewhat¿ but the surgical team was unable to remove the instrument and trocar.The ¿other instruments were used to straighten the scissors¿ and the trocar and ¿the scissors¿ were removed.The two ¿pieces of plastic¿ were removed through the ¿surgiquest trocar site with graspers¿.It was also noted that ¿a very small piece of plastic sheath¿ was removed superficially at/near the trocar incision.Upon visual inspection, no further pieces were noted.A new trocar and monopolar curved scissors (mcs) instrument were placed.The operative report indicated that the planned surgical procedure was successfully completed and that the patient tolerated the procedure well.The patient¿s current status is unknown.None of the products involved in this reported event have been returned to intuitive surgical, inc.(isi) for analysis.Based on the current information provided, this complaint is being reported because of the following: unintended fragments falling into the patient may require surgical intervention.At this time, the cause of the damage to the mcs tip cover accessory and the cause(s) of the patient¿s alleged operative and/or post-operative complications are unknown.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: DA VINCI
• Type of Device: TIP COVER ACCESSORY
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 10856026
• MDR Text Key: 216942897
• Report Number: 2955842-2020-11212
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 400180-07
• Device Catalogue Number: 400180
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/17/2020
• Supplement Dates Manufacturer Received: 06/07/2021
• Supplement Dates FDA Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Outcome(s): Other
• Patient Age: 60 YR