MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; SUCTION IRRIGATOR

Model Number 480299-06

Device Problem Difficult to Remove (1528)

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

Event Date 08/09/2023

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted surgical procedure the suction irrigator got stuck at the tip of the cannula when attempting to remove it.Prior to calling for support, the staff tried to remove the suction irrigator and the system generated a recoverable fault which was cleared.The suction irrigator and the cannula had to be removed together since it was stuck, and the surgery was continued without the use of a suction irrigator.The technical services engineer (tse) found one instance of error 282 in the error logs, pointing to the loss of tool sensors on arm 3, which may have been caused by pulling the suction irrigator too hard when attempting to remove it.The tse confirmed via logs and from the caller that all arms were working without problems at the time of the call.The tse suggested to send the suction irrigator for analysis.The procedure was continuing as planned with no reported injury.Intuitive surgical (is) contacted the site and obtained additional information regarding this event.The customer confirmed that the tip of the suction irrigator was damaged, but no part of it was detached.The customer could not confirm if there was any harm to the patient.There was delay of 10 minutes to the surgery because of the issue, and the surgery was completed with a backup instrument of the same kind.

Manufacturer Narrative

Intuitive surgical, inc.(isi) requested the return of the device for further evaluation.As of the date of this report, the suction irrigator has not yet been returned for analysis.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Intuitive surgical, inc.(isi) contacted the site and obtained the following additional information regarding this event: the customer confirmed that the port size was not increased due to the reported event.Isi received a da vinci product to perform failure analysis.The suction irrigator was analyzed and found to have the snake wrist dislodged from the distal cannula and no longer mated to the features that secure it with one another.The blue lumen was also found split into two pieces.No material appeared to be missing from the distal end assembly.Additional observation: the instrument was found to have all the snake wrist cables broken off at the wrist.As a result, the entire distal end was broken off as a whole unit including the distal tip, snake wrist, and lumen assembly.The customer returned the components of the distal end.No pieces appeared to be missing.The housing was split open, but no housing material appeared to be missing.The shaft was also no longer secured with the housing at the proximal end.

• Brand Name: ENDOWRIST
• Type of Device: SUCTION IRRIGATOR
• 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: 17706074
• MDR Text Key: 323010012
• Report Number: 2955842-2023-18308
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874114817
• UDI-Public: (01)10886874114817(10)M11230209
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K162973
• 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: 08/09/2023

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: 480299-06
• Device Catalogue Number: 480299
• Device Lot Number: M11230209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 09/07/2023
• Supplement Dates Manufacturer Received: 09/13/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.