MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; MONOPOLAR CURVED SCISSORS

Model Number 470179-19

Device Problem Difficult to Remove (1528)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

An investigation is in progress to determine the cause of this reported event.A return material authorization (rma) was issued to the customer requesting to have the intuitive surgical, inc.(isi) device returned.Isi has not received the instrument for failure analysis investigations.Additional information is being gathered to determine the contribution of the device to the customer reported issue.

Event Description

It was reported that during a da vinci-assisted left hemicolectomy surgical procedure, the monopolar curved scissors (mcs) instrument would not straighten and customer could not retrieve it out of port.When the customer tried to remove, the system lights flashed yellow and the customer was unable to advance or remove the robotic arm.The customer removed the arm and the port to remove the mcs instrument and had to place a larger port into patient due to larger hole from removing instrument.The mcs instrument tip was removed to reveal that orange plastic covering from under the mcs instrument had become dislodged and over the silver tip.This stopped the mcs instrument from becoming straight.The customer managed to force the orange plastic under the silver sheath to straighten the mcs instrument so that the port could be removed without breaking the instrument.The procedure was completed.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The monopolar curved scissors (mcs) instrument was analyzed and found to have a broken tube extension at the orange plastic section where it meets the proximal clevis.No pieces were missing.Thermal damage was not observed.An additional observation not reported by site that is related to the primary failure: the instrument was found to have a dislodged proximal clevis at the distal end.

Event Description

Refer to h10/h11 for follow-up information.

• Brand Name: ENDOWRIST
• Type of Device: MONOPOLAR CURVED SCISSORS
• 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: 18796235
• MDR Text Key: 336400964
• Report Number: 2955842-2024-11821
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K220023
• 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,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470179-19
• Device Catalogue Number: 470179
• Device Lot Number: K12230817 0577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/28/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2023
• 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