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

Model Number	470405-06
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the force bipolar (fb) instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigation was not able to confirm nor reproduce the reported complaint.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.The instrument release key was not used.The instrument was fully functional.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, a force bipolar (fb) instrument was unable to clamp, then unable to release.The customer had to use the emergency release key in order to remove instrument.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) follow-up and obtained the following additional information from the nurse: "while they were using the instrument, part of the tissue was getting tangled in the wrist.The jaws of the bipolar forceps instrument looked like it 'popped out' and 'locked up.'" they used a release wrench to open the jaws.Once they removed the instrument and removed all the tissue, they confirmed nothing was missing from the instrument.No fragments fell into the patient.

• 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: 17095449
• Report Number: 2955842-2023-16099
• Device Sequence Number: 1957497
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10200218
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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: N10200218 0253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2020
• 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