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

Model Number	470405-06
Medical Device Problem Codes	Break (1069); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the force bipolar instrument involved with this complaint, and completed the device evaluation.Failure analysis (fa) investigation found, the primary failure of severely bent grip tip to be related to the customer reported complaint.The instrument was found to have a severely bent grip.The prong near the conductor wire groove appeared to be bent outwards.The root cause of bent-severely instrument grips -tips is typically attributed to the user, such as excess force applied to the instrument jaws.Failure analysis found, the secondary failure of broken conductor wire to be related to the customer reported complaint.The instrument was found to have a broken conductor wire at the force clamp pulley at the distal end.The instrument failed the electrical continuity test.No sign of thermal damage was observed.The probable root cause of this failure is attributed to a component failure.Follow-up was attempted, but the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.
Event or Problem Description
It was reported, that during a da vinci-assisted ventral hernia surgical procedure.The force bipolar instrument allegedly locked onto tissue, and would not release the tissue.The surgeon was able to forcefully release the tissue from the instrument.The customer also reported, of noticing the broken wires on the instrument's tip.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained additional information: there was no damage to the patients tissue.No fragment fell into the patient.The or staff decided not to use the instrument.The procedure was completed robotically.With no injury to 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: 17016008
• Report Number: 2955842-2023-15111
• Device Sequence Number: 6975640
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10200907
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 07/22/2021

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: N10200907 0024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 05/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2020
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 210 KG