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

Model Number	470405-06
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, that the force bipolar instrument had a malfunction of arm wrist, a piece bulging out instead of being intact thereby causing restriction in the arm movement.The procedure was completed with no reported injury.The force bipolar instrument is a multi-use instrument with bipolar energy capability.This instrument is designed for dissection, grasping, retraction, and bipolar coagulation of tissue.This instrument allows the user to temporarily apply a strong grip mode, depending on surgical needs.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis investigations replicated/confirmed the customer reported complaint piece bulging out instead of being intact caused restriction in arm movement.The force bipolar instrument was found to have a severely bent grip, which is causing a side-to-side misalignment of the grips.There was a.021 side and.03 out of the clevis offset at the tips.As a result, when the instrument was placed on the in-house system the instrument failed the intuitive motion test.Because the grips do not open and close properly, it rubs against the clevis thereby preventing it from closing.Additional observation not reported by the site: the force bipolar instrument was found with both conductor wires with damage insulation.The black coding of the wire has some damage to the surface.No thermal damage found.Root cause of conductor wire damage insulation is attributed to a component failure.For clarification, the conductor damage did not puncture through exposing the cable, the insulation damage is only surface based.An electrical continuity test was performed and it passed.A review of the instrument log (attached) for force bipolar was (part - 470405-06/n10201006) associated with this event has been performed.Per logs, the force bipolar was last used on 12/04/2020 on system sk2115, with 2 lives remaining.

• 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: 17067927
• Report Number: 2955842-2023-15916
• Device Sequence Number: 20527015
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10201006
• 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,User Facility
• 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: N10201006 0124
• 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: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2020
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 93 KG