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

Model Number 420207-07

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the part associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint.For clarification, the tenaculum forceps instrument was found to have a broken pitch cable at the distal clevis hub, resulting in loss of motion at the wrist.The broken cable segment that contains the crimp was still installed in the clevis.Failure analysis found the primary failure of a broken pitch cable at the distal end of the instrument to be related to the customer reported complaint.Root cause of a broken pitch cable is a component failure.Additional observation not reported was that the main tube exhibits signs of scratch marks/abrasions on the distal end.Main tube scratch marks measured roughly 0.03" to 0.49" in length and were not aligned with the tube axis.Material was missing from the surface of the main tube.This failure is most commonly caused by mishandling/misuse, such as excessive contact with abrasive or hard surfaces during transport or reprocessing.Failure analysis found the additional failure of main tube scratch marks to not be related to the customer reported complaint.A site history was performed and no related complaints were found.A review of system logs showed that the tenaculum forcep was last used on system number (b)(4) on (b)(6) 2020 and it had 1 life remaining.No image or video was provided for review.Based on the information provided at this time, this complaint is being classified as a reportable malfunction event due to the following conclusion: the tenaculum forceps instrument is designed with two pitch cables, each with a crimp at the distal end.If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient.Although no patient harm was reported, if the issue that was found during failure analysis were to recur, it could cause or contribute to an adverse event.

Event Description

It was reported that during central processing, one controller wheel of the tenaculum forceps was spinning freely and it was not controlling anything.There was no patient involvement.Intuitive surgical, inc.(isi) made multiple follow-up attempts to obtain additional information.However, no further details have been received as of the date of this report.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: TENACULUM 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: david wang ; 3410 central expressway; santa clara, CA 95051 ; 4085232100
• MDR Report Key: 11219681
• MDR Text Key: 239500841
• Report Number: 2955842-2021-10082
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111659
• UDI-Public: (01)00886874111659(10)M10140210
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420207-07
• Device Catalogue Number: 420207
• Device Lot Number: M10142010 0533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1