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

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.

• Brand Name: ENDOWRIST
• Type of Device: FORCE 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 Key: 13003713
• MDR Text Key: 287613651
• Report Number: 2955842-2021-11740
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)K10210816
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• 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 Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: K10210816 0166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female