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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST FORCE BIPOLAR

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INTUITIVE SURGICAL, INC ENDOWRIST FORCE BIPOLAR Back to Search Results
Model Number 471405-06
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 11/16/2021
Event Type  Injury  
Event Description
It was reported that during a da vinci-assisted paraesophageal hernia repair, the bedside assist tried to raise the patient's head. At that time, the bed was pushing down on the "bair hugger" (a third party manufacturer product) that was under the foot of the bed. The "bair hugger" blower/heater is a box that is typically placed under the operating room table prior to the start of the case. The bedside assist pulled the "bair hugger" from under the bed, this caused the bed to drop a bit. As the robot was docked inside the patient, one of the da vinci instrument lacerated the liver. Intuitive surgical, inc. (isi) obtained the following additional information from the surgeon and the operating room staff regarding the reported event: during the procedure, the patient was in a reverse trendelenburg position. Thirty minutes into the procedure, the surgical staff tried to raise the patient's head. At that time, the bed was pushing down on the "bair hugger" under the foot of the bed. A bedside assistant pulled the "bair hugger" from under the bed; this caused the bed to drop a bit. The system was docked, and the surgeon's head was in the console. At that time, the installed force bipolar instrument lacerated the liver, and there was bleeding. The patient also experienced a hematoma in the esophagus. The surgeon reportedly repaired the liver laceration with cautery and let the esophageal hematoma heal independently. The surgeon planned to use the linx device on the esophagus to treat gerd. However, secondary to the hematoma, the surgeon discontinued the procedure. The surgeon and the site stated the leading cause was an issue with the communication between the bedside assist and the surgeon. The bedside assistant also accepted it was their mistake. However, the surgeon said he wished the system would give some messages indicating an obstruction. He was concerned that the trumpf table dropped without warning when the block below was removed. As the patient was from another state and the surgeon did not complete the procedure, the site will reschedule the procedure for free surgery later. There was no allegation that a da vinci system, instrument, or accessory malfunction occurred or caused/contributed to the injury reported.
 
Manufacturer Narrative
Based on the current information provided, the root cause of the customer reported operative complication is determined to be user error. There was no report or allegation of a specific deficiency of the da vinci system, instrumentation or accessories associated with the reported incident. Therefore, there are no products expected for return to intuitive surgical, inc. (isi) for failure analysis evaluation. If additional information is received, a follow-up mdr will be submitted. A review of the site's complaint history does not reveal any additional complaints involving this this event. No image or video clip for the reported event was submitted for review. A system log review was performed for the procedure date of (b)(6) 2021. Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint. Additionally, the force bipolar instrument used during the procedure has been used in subsequent procedures. This complaint is being reported due to the following conclusion: during a da vinci-assisted paraesophageal hernia repair, the bedside assist tried to raise the patient's head. At that time, the bed was pushing down on the "bair hugger" that was under the foot of the bed. The bedside assist pulled the "bair hugger" from under the bed, which caused the bed to drop a bit. As the robot was docked inside the patient, the force bipolar instrument lacerated the liver and esophagus due to mechanical trauma as the patient was pushed into the instruments. The cause of the reported issue is related to the user issue.
 
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Brand NameENDOWRIST
Type of DeviceFORCE BIPOLAR
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer Contact
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key13003713
MDR Text Key287613651
Report Number2955842-2021-11740
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180351
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 11/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number471405-06
Device Catalogue Number471405
Device Lot NumberK10210816 0166
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/17/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/12/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/14/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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