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

Model Number	470405-06
Medical Device Problem Codes	Difficult to Open or Close (2921); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted inguinal hernia repair surgical procedure, the surgeon was manipulating tissue when the force bipolar instrument joint broke and was stuck on the tissue.The site had tried the instrument release kit (irk) to open the instrument jaws but was not able to.The site ended up manipulating the stuck instrument jaws with another instrument to get the jaws to open and was able to get the instrument out.The site continued with the case.The customer will send back the instrument for evaluation.The procedure was completed as planned with no reported injury.Intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: the instrument was inspected prior to use and there was nothing out of the ordinary.There was no instrument collision during the procedure.The hinge popped off when the instrument was at the most limit of the wrist articulation.No fragment fell inside the patient and it was confirmed there was no patient harm.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigations did not replicate nor confirm the customer reported complaint of "the instrument would not release the grip upon inspection of the instrument, it was found to have a dislodged arm on the endowrist of the instrument".Upon visual and microscopic inspection, no damage was found to the wrist assembly.No cable damage or misalignment of the grips was observed.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips opened and closed properly, and the grip function performed successfully.The instrument is fully functional.No use of an instrument release kit was needed during the in-house testing.

• 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: 17016003
• Report Number: 2955842-2023-15108
• Device Sequence Number: 12506389
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10200121
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/04/2020

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: N10200121 0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 05/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2020
• 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