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

Model Number 471405-06

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted inguinal hernia repair procedure, the force bipolar instrument could not be unclamped and the jaw was dislodged.The customer was unable to remove the instrument through the cannula.Technical support advised the customer to remove the instrument and cannula together.Customer then informed that a piece of the instrument was protruding and was in contact with the patient's abdominal wall.Intuitive surgical, inc.(isi) followed up with the surgeon and obtained the following information: in the beginning of the procedure, fat/peritoneum kept on getting stuck at the wrist of the instrument and the surgeon would nudge it out with the monopolar curved scissors (mcs).Once, the surgeon cut off a few mm of peritoneum tissue to release the instrument.He did not have to do any repairs and the cut tissue did not cause any permanent functional impairment to the patient.About midway into the procedure, the surgeon was trying to reduce the hernia sac and was grasping fat tissue.There was tissue stuck in the wrist and the jaws would not unclamp.The surgeon tried to use the instrument release kit (irk) to release tissue, but the jaws only moved side to side and not open/close.The surgeon cut a few mm of fat tissue to release the instrument.The cut tissue did not require any repair.The wrist of the instrument was also dislodged, and the instrument could not be removed through the cannula.The surgeon tried to remove the instrument and cannula together subsequently, but the dislodged jaw was in contact with the patient's tissue at the abdominal wall when pulling through the abdominal wall.The tissue was not injured.The surgeon then used the mcs to push the force bipolar wrist in place and the force bipolar was removed through the cannula without any issues.There was no bleeding and no tissue repairs that were required due to the issue.There was no fragment from the instrument that fell into the patient.The surgeon completed the procedure with a backup fenestrated bipolar forceps.The patient did not have any post-operative complications and was discharged the same day.

Manufacturer Narrative

Isi received the force bipolar instrument involved with this complaint and completed the failure analysis (fa) testing.Fa found the primary failure of severely bent grip tip to be related to the customer reported complaint.The instrument had a severely bent grip at the conductor wire groove.The grip base was found to be protruding outwards at the distal wrist.The root cause of this failure is typically attributed to user mishandling, such as excess force applied to the instrument jaws.An additional observation not reported by the site was also identified.The instrument was found to have insulation damage on the conductor wire, exposing the internal wires.The damage was located at the distal end at the conductor wire groove.No material was missing and no thermal damage was observed.An electrical continuity test passed.The root cause of this failure is attributed to a component failure.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or video clip for the reported event was submitted for review.A review of the system and instrument logs has been performed.There were no observed events in the available system logs that would suggest a product issue, and logged events are in line with normal system functionality.Although none of the reusable instruments were reused in subsequent procedures, a site review shows no complaint filed against the instruments.This complaint is reportable due to the following: during a da vinci-assisted inguinal hernia repair procedure, tissue was getting stuck at the wrist of the force bipolar instrument and the surgeon used the mcs to release the instrument and cut peritoneal tissue.The force bipolar instrument jaw got dislodged at the proximal end as well and the instrument failed to unclamp.The instrument, which was grasping fat tissue, could not be opened by the instrument release kit (irk).The surgeon cut tissue to release the instrument.The surgeon attempted to remove the cannula and instrument together at the abdominal wall but was unable to as the protruding jaw of the force bipolar was in contact with the abdominal wall internally.The surgeon used a mcs to push the wrist of the force bipolar back in and removed the instrument without any further issues from the cannula.A backup fenestrated bipolar forceps was used, and the procedure was completed with no injury to the patient.The surgeon did not have to repair the abdominal wall tissue or the fat tissue that was resected.The patient did not have any post-operative complications and was discharged the same day.This complaint is considered a reportable malfunction as the grips were stuck due to the jaw being dislodged and could not be opened by the irk.The fat tissue that was cut was a few mm wide and did not require any repair.According to the surgeon, the cut tissue did not cause any permanent functional impairment to the patient.

• 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: 13573688
• MDR Text Key: 296399748
• Report Number: 2955842-2022-10316
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874120767
• UDI-Public: (01)00886874120767(10)N10210426
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: N10210426 0111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2021
• 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: Male