MAUDE Adverse Event Report: INTUITIVE SURGICAL DA VINCI XI; MONOPOLAR CURVED SCISSORS

Model Number 470179

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/24/2017

Event Type  malfunction  

Event Description

Using davinci xi monopolar scissors and a piece of the plastic broke off of the instrument and into the patient.Plastic was retrieved from the abdomen.Instrument reference # 470179, ver -14 and lot # s10161130 0053.

• Brand Name: DA VINCI XI
• Type of Device: MONOPOLAR CURVED SCISSORS
• Manufacturer (Section D): INTUITIVE SURGICAL
• MDR Report Key: 6995774
• MDR Text Key: 90942290
• Report Number: MW5073079
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470179
• Device Lot Number: S10161130 0053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR