MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. HOT SHEARS MONOPOLAR CURVED SCISSORS; SYSTEM, SURGICAL, COMPUTER CONTROLLER

Model Number 420179

Device Problem Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/06/2018

Event Type  Injury  

Event Description

Accessory sheath for robotic monopolar scissors was noted to be missing upon removal of instrument from pt.An extensive search was conducted, initially unsuccessful in locating the sheath using x-ray and converting to open surgery to locate.The pt was closed and sent for ct scan which identified the location.The pt was returned to the operating room and the sheath was removed.Pt for robotic hysterectomy/salpingectomy and symptomatic fibroid removal.

• Brand Name: HOT SHEARS MONOPOLAR CURVED SCISSORS
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA 94086
• MDR Report Key: 8079076
• MDR Text Key: 127618764
• Report Number: MW5081382
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 420179
• Was Device Available for Evaluation?: Yes
• 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: 0
• Patient Outcome(s): Hospitalization
• Patient Age: 49 YR
• Patient Weight: 83