MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Model Number 470179

Device Problem Component Missing (2306)

Patient Problem No Code Available (3191)

Event Date 12/12/2018

Event Type  Injury  

Event Description

During a robotic laparoscopic hysterectomy completion, all instruments were removed and the surgeon began closing.During the instrument count it was noted that the "tip cover accessory" was missing from the robotic monopolar curved scissors instrument/hand piece.Inspection of the instrument noted that the placed rf insulation tip was missing.Inspection of the instrument tray and surrounding area did not locate the tip assembly.An x-ray unit was brought into the surgery room and imaging did not reveal tip assembly.The patient was then sent for ct scan and imaging did reveal tip assembly still retained in patient.The patient was prepped for an exploratory laparotomy and the tip was recovered and sequestered for reporting and risk management.Surgical technicians did note that initial placement of the insulation tip was followed correctly to cover orange sight band located on the distal end of the robotic instrument.Biomedical also confirmed installation and removal of tip from handpiece followed normal interference fit requiring silicon assembly tool to assist in setting insulation tip in place.Tip assembly was used to protect handle curved scissors cabling and to provide rf isolation during monopolar electrosurgical activation.Both robotic monopolar scissors and tip assembly was sequestered for risk mgt and mfg follow up.Manufacturer response for tip cover assembly, da vinci xi (per site reporter).Manufacturer and facility risk mgt still discussing incident.No additional information.Manufacturer response for robotic monopolar curved scissors, da vinci xi (per site reporter) manufacturer and facility risk management still discussing issue.No further information available.

• Brand Name: ENDOWRIST
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 8178216
• MDR Text Key: 130789086
• Report Number: 8178216
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470179
• Device Catalogue Number: 470179
• Device Lot Number: N10809260180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 24820 DA