MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI XI FENESTRATED BIPOLAR FORCEPS INSTRUMENT

Model Number 470205

Device Problems Break (1069); Difficult to Open or Close (2921); Material Protrusion/Extrusion (2979)

Patient Problem No Code Available (3191)

Event Date 04/18/2017

Event Type  Injury  

Event Description

It was reported that during a da vinci xi hysterectomy procedure, the fenestrated bipolar forceps instrument spring was broken after it was hooked to robot.The report revealed the grasps would not open or close with the spring protruded.No patient harm was reported.The device was returned to the manufacturer.

• Brand Name: DA VINCI XI FENESTRATED BIPOLAR FORCEPS INSTRUMENT
• Type of Device: DA VINCI XI FENESTRATED BIPOLAR FORCEPS INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA 94086
• MDR Report Key: 6585236
• MDR Text Key: 75867383
• Report Number: MW5069947
• Device Sequence Number: 1
• Product Code: NAY
• 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: 05/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470205
• Device Lot Number: N111611250011
• 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: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Weight: 116