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

Model Number	420110-12
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the precise bipolar forceps instrument involved with this complaint and completed the device evaluation.Failure analysis investigations confirmed the customer reported complaint.The instrument was found to have a broken conductor wire at the yaw pulley.The conductor wire was broken at the grip-crimp location and the instrument failed the electrical continuity test.No signs of thermal damage were observed.An additional observation not reported by the site was that the instrument was found to have a broken bipolar yaw pulley.A broken piece measuring approximately 0.096 x 0.165 was missing as a result of the breakage.This failure is typically associated with mishandling/misuse., such as excess force applied to the distal end of the instrument.
Event or Problem Description
It was reported that prior to starting a da vinci-assisted surgical procedure, the inspection of the precise bipolar forceps instrument identified physical damage on the conductor wire insulation.Planned use of the instrument was discontinued.Following this, the user continued the planned procedure with no further issue reported.No fragment fell into the patient's anatomy.There was no known impact or patient consequence was reported.

• Brand Name: ENDOWRIST;DAVINCI SI
• 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: 16925272
• Report Number: 2955842-2023-13187
• Device Sequence Number: 6931003
• Product Code: NAY
• UDI-Device Identifier: 00886874111352
• UDI-Public: (01)00886874111352(10)N10201218
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 10/05/2021

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: 420110-12
• Device Catalogue Number: 420110
• Device Lot Number: N10201218 487
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2020
• 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 Sex: Female