MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. SINGLE-SITE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number VER 03

Device Problems Break (1069); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2018

Event Type  malfunction  

Event Description

Patient was scheduled for robotic laparoscopic cholecystectomy with grams, during the process of the procedure; a crocodile xi instrument was used and broke inside the patient's abdomen.A piece of the instrument jaw that was broken was recovered and was easily removed while the other piece required an x-ray to determine its location.X ray was done and the missing piece was located and removed inside the patient's abdomen.Upon inspection by the surgeon, the or personnel and the robot representative, everyone agreed that all the missing pieces were recovered and no other instrument piece/s were left inside the patient.Per site reporter: no response form manufacturer yet.

• Brand Name: SINGLE-SITE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): INTUITIVE SURGICAL INC.; 1266 kifer rd; sunnyvale CA 94086
• MDR Report Key: 7490008
• MDR Text Key: 107484123
• Report Number: 7490008
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2018

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: Physician
• Device Model Number: VER 03
• Device Catalogue Number: 478059
• Device Lot Number: S10170620 0132
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/03/2018
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DAVINCI ROBOTIC SYSTEM
• Patient Age: 53 YR