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

Model Number	420110-10
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the precise bipolar forceps instrument jaws would not open.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the jaws of the precise bipolar forceps instrument would not open.The issue was identified during surgery and caused a procedure delay of less than 15 minutes.The procedure was completed using a backup instrument with no adverse effect or injury to the patient.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the precise bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigation found the instrument to have a broken conductor wire at the yaw pulley.The conductor wire was broken at the grip-crimp location.The instrument failed the electrical continuity test.There were no signs of thermal damage observed.The instrument was found to have a broken bipolar yaw pulley.A broken piece approximately 0.068 x 0.120 in size was missing as a result of breakage.This failure is typically associated with mishandling/misuse, such as excess force applied to the distal end of the instrument.The instrument was found to have a bent grip, causing side to side misalignment of the grips.There was a 0.024 offset at the tips.The grip tips was also found to have various scratch marks.The instrument was found to have various scratch marks with light material removed on the main tube.The scratch marks were 0.070 - 0.196 in length and were not aligned with the tube axis.This failure is typically associated with mishandling/misuse.

• Brand Name: ENDOWRIST
• Common Device Name: PRECISE BIPOLAR FORCEPS
• 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: 16925267
• Report Number: 2955842-2023-13185
• Device Sequence Number: 15186052
• Product Code: NAY
• UDI-Device Identifier: 00886874111352
• UDI-Public: (01)00886874111352(10)N10180705
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/09/2020

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: 420110-10
• Device Catalogue Number: 420110
• Device Lot Number: N10180705 084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/04/2018
• 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