MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI FORCE BIPOLAR; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 471405

Device Problems Break (1069); Difficult to Remove (1528); Difficult to Open or Close (2921)

Patient Problems Laceration(s) (1946); Unspecified Gastrointestinal Problem (4491)

Event Date 06/13/2023

Event Type  Injury  

Event Description

The gear/cable mechanism of the fenestrated force bipolar broke while grasping the stomach.The instrument could not be opened (with help of intuitive support - would not open w/irk) so the stomach was forcibly removed which caused a large hole in the stomach.Stomach repaired in 2 layers, leak test on egd was negative.Unable to complete the paraoesophageal hernia repair as planned - performed gastropexy instead.

• Brand Name: DA VINCI FORCE BIPOLAR
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 17163735
• MDR Text Key: 317734338
• Report Number: MW5118476
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/15/2023

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: 471405
• Device Lot Number: K102301220090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White