MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; DOUBLE FENESTRATED GRASPER

Model Number 420189-12

Device Problems Unintended System Motion (1430); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/05/2020

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure, the double fenestrated grasper instrument was unable to be removed from the arm and had to be removed with force.The procedure was completed with a backup instrument and there was no reported injury.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the double fenestrated grasper instrument involved with this complaint and completed the device evaluation.Failure analysis investigation did not confirm the reported failure.Failure analysis found the instrument was installed and removed several times from the systems arm with no issues.The instrument passed the recognition and engagement tests when it was placed and driven on an in-house system.This instruments grip tips were not moving intuitively, i.E.They were not following the surgeon side console (ssc) master tool manipulator (mtm) input commands smoothly.The instrument was transferred to engineering for further evaluation.The instrument was re-tested on in-house system and non-intuitive motion was confirmed.Grips opened/closed properly, but pitch and yaw motions at wrist were opposite of the mtm commands.After removing the instrument, it was observed that the main tube orientation at the "home position (initial orientation upon completion of instrument engagement) was off by nearly 180 degrees compared to a known good instrument.With instrument main tube manually rotated to home position, the roll gear tab was confirmed to be in a different location compared to a known good instrument.Roll gear was able to be removed and re-installed to correct orientation, and it was confirmed that this resolved the non-intuitive motion.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: DOUBLE FENESTRATED GRASPER
• 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: 17067239
• MDR Text Key: 317539804
• Report Number: 2955842-2023-15664
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111581
• UDI-Public: (01)00886874111581(10)N10190502
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/24/2020

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
• Device Operator: Health Professional
• Device Model Number: 420189-12
• Device Catalogue Number: 420189
• Device Lot Number: N10190502 297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 09/24/2020
• Initial Date FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2019
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES