MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; CLIP APPLIER, SMALL, HORIZON

Model Number 470401-07

Device Problem Failure to Sense (1559)

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

Event Date 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

Intuitive surgical, inc.(isi) did receive a da vinci product to perform failure analysis.The horizon clip applier instrument and failure analysis investigations not replicated nor confirmed the customer reported complaint.Failure analysis found the primary failure of could not reproduce to be related to the customer reported complaint.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.There was no report of recognition or engagement failure during procedure on the system as the instrument was not used and has 100 out of 100 lives in it.Additional observations not reported by site: the horizon clip applier instrument was found to have corrosion/contamination on the bearings.An input disk bearings exhibited orange discoloration.The instrument was found to have a broken distal pitch cable at the proximal clevis hub.The broken cable segment that contains the crimp was still installed in the clevis.The cable was fully broken.There were evidence of discoloration or corrosion/ contamination on the cable to indicate a reprocessing induced issue.The components surrounding to the broken cable did not exhibit abnormal sharp edges or damage that would have contributed to the cable breaking.The instrument was found to have one of the pitch cables broken at the proximal end in the housing.The pitch cable was broken at the backend pulleys.The clamping pulley did exhibit signs of corrosion/contamination/ residue that would have contributed to the broken cable.The instrument was found to have an excessive amount of dried, white residue on the clamping pulley of inputs #[5 (pitch), 6 (grip) , 7 (grip) located in the backend of the instrument.The groove surfaces exhibited a residual, powder-like deposit, that could be removed by wiping.

Event Description

It was reported that during a da vinci-assisted esophagectomy surgical procedure, the horizon small clip applier instrument would not calibrate on the arm.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST
• Type of Device: CLIP APPLIER, SMALL, HORIZON
• 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: 18918864
• MDR Text Key: 337854512
• Report Number: 2955842-2024-12537
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112670
• UDI-Public: (01)00886874112670(11)210708(10)N10210712
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K150837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470401-07
• Device Catalogue Number: 470401
• Device Lot Number: N10210712 0003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: ISIFA2022-05-C
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Sex: Male