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 Unspecified Tissue Injury (4559)

Event Type  Injury  

Event Description

It was reported that a few months after a da vinci assisted procedure, the patient returned to the emergency room because the clip applier had eroded into the duct.There was no known injury at the time the procedure was performed.

Manufacturer Narrative

No product has been returned to intuitive surgical, inc.(isi) for evaluation.Insufficient procedural details do not allow for further log review investigation.

• 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: 18449147
• MDR Text Key: 332162674
• Report Number: 2955842-2023-21878
• Device Sequence Number: 1
• Product Code: NAY
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/06/2023

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: 470230-12
• Device Catalogue Number: 470230
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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