MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; FORCE BIPOLAR

Model Number 471405-06

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the cause of the reported complication cannot be determined.The following investigations could not be performed due to insufficient information provided (system serial number, site information, surgeon name): site history, event verification, system/instrument log review.

Event Description

On 1/02/2024, intuitive surgical, inc.(isi) received mw5149161 stating: force bipolar grasper (#1) instruments tissue getting caught in hinge going of grasper repeatedly interfering with operation.Force bipolar grasper (#2) tissue getting caught in hinge joint of grasper repeatedly interfering with operation, tip of instrument broke apart inside of patient (intact but broken).Tissue torn as instrument removed from patient due to inability to get instrument inside port while removing before of broken edge.See attachment.Isi was unable to determine site/account due to no contact/hospital information provided from regulatory report.

• Brand Name: ENDOWRIST
• Type of Device: FORCE BIPOLAR
• 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: 18573791
• MDR Text Key: 333661785
• Report Number: 2955842-2024-10174
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K214095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: 505
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471405-06
• Device Catalogue Number: 471405
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2024
• 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.