MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; TIP-UP FENESTRATED GRASPER

Model Number 470347-11

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 09/22/2023

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted low anterior resection surgical procedure, the part between the wrist and the shaft of the tip-up fenestrated grasper (tufg) instrument was broken due to a collision with the other instrument.The tufg instrument could not be removed because it was stuck in the cannula.The customer had to remove the cannula and the tufg together.No fragment fell inside the patient.The procedure was completed with no reported injury.Intuitive surgical inc.(isi) followed up with the initial reporter and obtained the following additional information: the surgeon did not perform port incision enlargement to remove the instrument.The customer confirmed that no fragment falling into the patient¿s anatomy.The patient did not return to the hospital for any post-surgical complications.

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The tip-up fenestrated grasper (tufg) instrument was analyzed and found to have the main tube broken.A piece measuring proximately 0.201¿ x 0.145¿ was broken off the instrument.The instrument housing was removed, and the clamping pulley screws were loosened to separate the main tube from the proximal clevis.Visual inspection found all internal cables to be still intact but there is a possibility of missing material.There was a chunk of material missing, and the material was unable to be found on the inside of the main tube.The complaint was confirmed by failure analysis, which indicates that the device may have contributed to the customer reported issue.Blank mdr fields: the missing patient information in sections a and b was either unknown, unavailable, not provided, or not applicable.The expiration date for section d4 is not applicable.Field d6 is blank because the product is not implantable.Information for the blank fields in section e1 is not available.Fields g5 and g7 are not applicable.

• Brand Name: ENDOWRIST
• Type of Device: TIP-UP 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: 18548599
• MDR Text Key: 333484025
• Report Number: 2955842-2024-10511
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112496
• UDI-Public: (01)00886874112496(11)230525(10)K14230525(91)0001
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/02/2024

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: 470347-11
• Device Catalogue Number: 470347
• Device Lot Number: K14230525 0168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2023
• 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