MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; PK DISSECTING FORCEPS

Model Number	420227-07
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During a da vinci assisted prostatectomy procedure, it was reported that the prongs of the pk dissecting forceps instrument were bent.The procedure was completed and there was no patient injury reported.
Additional Manufacturer Narrative
Intuitive surgical, inc.(isi) received the pk dissecting forceps instrument involved with this complaint and completed the device evaluation.The instrument was found to have a bipolar pin bent.This failure is typically associated with mishandling/misuse, such as an accidental drop or excessive force applied when trying to connect the instrument to an incorrect energy cable, which can cause the pin to bend.The main tube was also found to be broken with no material missing.There were various scratch marks with light material removed on the main tube.The scratch marks were 0.169¿ * 0.19" in length and were not aligned with the tube axis.This failure is typically associated with mishandling/misuse.The instrument was also found 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.No signs of thermal damage were observed.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: PK DISSECTING 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: 16925257
• Report Number: 2955842-2023-13180
• Device Sequence Number: 20565521
• Product Code: NAY
• UDI-Device Identifier: 00886874111673
• UDI-Public: (01)00886874111673(10)N10181206
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K061260
• 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): 08/25/2020

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: 420227-07
• Device Catalogue Number: 420227
• Device Lot Number: N10181206 630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2018
• 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