MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST CADIERE FORCEPS; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 470049

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/03/2021

Event Type  malfunction  

Event Description

The procedure performed was an xi assisted laparoscopic paraesophageal hiatal hernia repair.Xi cadiere forceps were among the instruments used during this case.During the use of the cadiere forceps, half of the forceps tip broke off inside the patient.The surgeons in the console retrieved the broken piece with another robotic instrument.With the assistance of an already placed 11mm port, the intern at bedside used a laparoscopic grasper (d&g) to pull the broken piece out of the abdomen.The intern then removed the broken cadiere forceps from the abdomen and the robot arm.The instrument and broken piece were taken off the sterile field and sequestered to return to the company.The console surgeons examined the abdomen and confirmed no remaining pieces were left behind.Manufacturer response for robotic cadiere forceps, (brand not provided) (per site reporter).Pending evaluation of device.

• Brand Name: ENDOWRIST CADIERE FORCEPS
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 12007884
• MDR Text Key: 256460976
• Report Number: 12007884
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/10/2021

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: 470049
• Device Catalogue Number: 470049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA