MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; LARGE HEM-O-LOK CLIP APPLIER

Model Number 470230-12

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 06/15/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the claim against the product by the customer noting an issue with an insturment, an investigation was completed to determine the cause of this reported event.The large hem-o-lok clip applier instrument was analyzed and found to have failed the clip test due to misapplication of the clip.The instrument passed engagement and was able to retain the clip, but it could not apply the clip.The instrument was found to have a loose grip cable, which caused it to fail to apply the clip to the test tubing on multiple attempts.Additional observation(s) not reported by the site: the instrument was found to have a loose grip cable at the distal end.The complaint regarding issue with the instrument was confirmed by failure analysis, which indicates that the device did contribute to the customer reported issue.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the large hem-o-lok clip applier instrument was broken.There is no further information available.Intuitive surgical, inc.(isi) followed up with the initial reporter; however, the customer could not provide any additional information.

• Brand Name: ENDOWRIST
• Type of Device: LARGE HEM-O-LOK CLIP APPLIER
• 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: 17647457
• MDR Text Key: 322266467
• Report Number: 2955842-2023-18085
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112380
• UDI-Public: (01)00886874112380(10)N10190826
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 08/21/2023

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: 470230-12
• Device Catalogue Number: 470230
• Device Lot Number: N10190826 0044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2019
• 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