MAUDE Adverse Event Report: INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS

Lot Number N10180112

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/07/2018

Event Type  malfunction  

Event Description

During initial survey of abdomen laparoscopically, a black ring was noticed and removed.Upon further investigation, the black ring was found to be a piece of the intuitive instrument which had broken off and fallen into the pt's abdomen.This incident didn't cause pt harm or require any add'l intervention.

• Brand Name: MONOPOLAR CURVED SCISSORS
• Type of Device: MONOPOLAR CURVED SCISSORS
• Manufacturer (Section D): INTUITIVE SURGICAL
• MDR Report Key: 7316471
• MDR Text Key: 101715639
• Report Number: MW5075663
• 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: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: N10180112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 39 YR
• Patient Weight: 87