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

Model Number	470405-06
Medical Device Problem Codes	Premature End-of-Life Indicator (1480); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the force bipolar involved with this complaint and completed the device evaluation.Failure analysis did not confirm nor replicate the reported complaint.The instrument was returned with 0 lives remaining.A review of remotefe log confirms that the instrument has 0 lives remaining and has expired.The life indicator has turned red, indicating that the instrument has expired.The expired instrument is in expected condition.Additional observations, which were not reported by site: the instrument was found to have damage of the conductor wires insulation.Electrical continuity was performed and failed.No thermal damage observed.The instrument was found to have various scratch marks with light material removed on the main tube.The scratch marks were 0.047 - 0.091 in length and were not aligned with the tube axis.
Event or Problem Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the force bipolar expired prematurely.There was no patient involvement.

• 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: 17067928
• Report Number: 2955842-2023-15917
• Device Sequence Number: 20527016
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N11190729
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 02/26/2021

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: N11190729 0126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2019
• 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