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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 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.
 
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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 Key13573688
MDR Text Key296399748
Report Number2955842-2022-10316
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 01/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471405-06
Device Catalogue Number471405
Device Lot NumberN10210426 0111
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/22/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 02/21/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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