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

Model Number	471171-15
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The micro bipolar forceps instrument was analyzed and failure analysis investigations did not replicate nor confirm the customer-reported complaint " teeth do not match".The instrument underwent an external visual inspection, which confirmed the absence of any issues related to bending.However, the instrument was found to have conductor wire insulation damage and yaw pulley thermal damage.The instrument was found to have damage to the conductor wire's insulation at the yaw pulley.There was no material missing and the conductor wires were not exposed.The conductor wire insulation was damaged, but the wire was not torn or fully broken.The instrument passed an electrical continuity test.Additionally, the instrument was found to have charring and localized melting at the yaw pulley.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.Field d6 is blank because the product is not implantable.
Event or Problem Description
It was reported that during a da vinci-assisted surgical procedure, the teeth of the micro bipolar forceps instrument did not match.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST
• Common Device Name: MICRO BIPOLAR FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 19630458
• Report Number: 2955842-2024-16270
• Device Sequence Number: 15651748
• Product Code: NAY
• UDI-Device Identifier: 00886874121474
• UDI-Public: (01)00886874121474(10)K10220124
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K214095
• 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): 06/24/2024

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: 471171-15
• Device Catalogue Number: 471171
• Device Lot Number: K10220124 0033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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: Prefer Not To Disclose