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

Model Number	470405-06
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation did not replicate the customer complaint of the grips being stuck; however, the grip tips were found to be bent.Visual inspection of the instrument found the base of the grip to be severely bent, sticking out of the distal clevis which prevented the jaw to open properly.This failure is most commonly caused by mishandling/misuse, such as excess force applied to the instrument jaws.The investigation was escalated to advanced failure analysis.Additional engineering review noted that it was visually verified that the proximal end of the grips were bent just to the outside of the distal clevis.The instrument was installed on an in-house system for further testing.The instrument passed through the cannula and was recognized by the system.When the engineering team used the master tool manipulator (mtm) on the surgeon side console (ssc), they were able to manipulate the instrument and cause the grips to open and close.However, due to the bent nature of the grips, the range the grips could move was limited compared to a normal force bipolar instrument.It was noted the customer complaint of the grips becoming stuck while in strong grip mode was attempted to be replicated by activating the mode while gripping an object, but the grips were able to release normally.This grip test was attempted multiple times and each time the grips were able to release properly.Once the grip was verified, the engineering attempted to remove the instrument from the cannula, but the bent grip became caught on the distal end of the cannula and required force to be pushed through.The force bipolar instrument grips were then removed from the maintube and no defects or abnormalities were found on the grips or the hypotubes.
Event or Problem Description
It was reported that during a da vinci-assisted liver resection surgical procedure, the customer noted the force bipolar instrument would not release from the tissue.The customer observed the instrument became sheared when removing from the patient.There was no reported injury.Isi followed up with the initial reporter and obtained the following additional information: the robotic coordinator (roco) informed the force bipolar released the tissue and no injury occurred.No fragments fell into the patient.The roco then stated the surgeon elected to convert to laparoscopic surgery because he felt the hernia repair procedure would be easier.It was noted that no troubleshooting was conducted with technical support prior to the conversion.The roco confirmed the procedure was completed laparoscopic with no patient injury or harm.In addition, the or coordinator informed that he spoke to the surgeon who informed that the strong grip mode was on at the time of the bipolar forceps was stuck on the tissue.The roco stated that the surgeon had to cut fatty tissue around the jaws and remove the instrument.It was indicated that the fatty tissue was not part of the planned procedure and was not intended to be removed.No medical intervention was required.The procedure was completed with no patient injury or harm.

• Brand Name: ENDOWRIST
• Common Device Name: 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: 17093857
• Report Number: 2955842-2023-16100
• Device Sequence Number: 19315785
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10191111
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K180351
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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
• Operator of Device: Health Professional
• Device Model Number: 470405-06
• Device Catalogue Number: 470405
• Device Lot Number: N10191111 0172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown