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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL,INC. TIP COVER ACCESSORY ENDOSCOPIC ELECTROSURGICAL INSTRUMENT ACCESSORY Back to Search Results
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.
 
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Brand NameTIP COVER ACCESSORY
Type of DeviceENDOSCOPIC 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 Key7174798
MDR Text Key97857084
Report Number2955842-2018-00017
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 12/15/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/09/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400180-14
Device Lot NumberM10171003
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2017
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

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