MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. TIP COVER ACCESSORY; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY

Model Number 400180-14

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

The tip cover accessory has not been returned to isi for failure analysis; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if additional information is received.Based on the provided information, this complaint is being reported due to the following conclusion: during a da vinci assisted surgical procedure, the tip cover accessory fell inside the patient and was retrieved.Although no patient harm, adverse outcome or injury was reported it is unknown what caused the tip cover accessory to slip off from the instrument and fall into the patient.

Event Description

It was reported that during a da vinci-assisted surgical procedure, it was noted that the tip cover accessory slipped off of the monopolar curved scissors (msc) instrument and fell in the abdomen.Customer felt the issue was more with the tip cover accessory than with the mcs instrument.The tip cover accessory was retrieved during the same procedure using traditional laparoscopic technique.No post-operative test was performed to check for remaining fragments as the site felt there was no need for it.There was no report of patient harm, adverse outcome or injury.On january 05, 2018, the following additional information was provided by the initial reporter: the surgical procedure was a robotic assisted total laparoscopic hysterectomy - bilateral salpingo-oophorectomy with the xi robot.The monopolar curved scissors (mcs) instrument was installed in arm 4 during the dissection and colpotomy part of the procedure which took about 45 minutes to complete.The scissors were removed by the rnfa after the colpotomy was completed and she noted that the tip cover accessory was missing from the scissors when she handed this instrument back to the scrub tech.As she was advancing the megasuturecut needle driver instrument down the trocar, it was noted that the tip cover fell out of the trocar and into the abdominal cavity.The robot was undocked and using the xi 0 degree endoscope and a laparoscopic maryland forceps instrument, the rnfa and the attending surgeon were able to locate, grasp and remove the tip cover.The tip cover was noted to be intact and complete with no tears.The patient suffered no injury and was transported to pacu after she successfully was awoken and extubated by anesthesia.Patient was of average height and weight.No recording of this procedure was done.

• Brand Name: TIP COVER ACCESSORY
• Type of Device: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 7174798
• MDR Text Key: 97857084
• Report Number: 2955842-2018-00017
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 400180-14
• Device Lot Number: M10171003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1