MAUDE Adverse Event Report: INTUITIVE SURGICAL DA VINCI TIP UP; SYSTEM SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Lot Number N10170830 0047

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 11/29/2017

Event Type  Injury  

Event Description

During the robotic portion of the surgery, the tip-up fenestrated grasper stopped working and was removed from the abdomen by dr.(b)(6).Upon visual inspection of the instrument, one of the wires was no longer intact.The instrument was not used for the remainder of the procedure.Wire thought to have snapped in half during case.Pt returned to ed for back pain and an x-ray was taken for that cc.At that time a small (less than 9mm) piece of frayed wire was seen in pt - rfo.

• Brand Name: DA VINCI TIP UP
• Type of Device: SYSTEM SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL
• MDR Report Key: 7178964
• MDR Text Key: 96990920
• Report Number: MW5074496
• 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: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Lot Number: N10170830 0047
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/09/2018
• 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): Other
• Patient Age: 54 YR
• Patient Weight: 57