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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOSCOPIC ELECTROSURGICAL INSTRUMENT TIP COVER 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 05/29/2018
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the tip cover accessory involved with this complaint and completed the investigation. Failure analysis was unable to confirm the customer reported failure. The reported symptom was not found related to the reported accessory. Visual inspection of the tip cover did not find any pieces missing from the distal or proximal ends. The tip cover was installed on an in house instrument and installed on a system. The instrument was installed and removed through a cannula without an issue; tip cover did not slide off. The monopolar curved scissors (mcs) instrument related to this event has not been returned for evaluation. A follow-up mdr will be submitted if additional information is received. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, the mcs tip cover accessory allegedly detached and fell inside the patient. The tip cover accessory was retrieved. Although, no patient harm was reported at this time it is unknown what caused the tip cover accessory to fall off inside the patient.
 
Event Description
It was reported that during a da vinci-assisted surgical procedure, the monopolar curved scissors (mcs) tip cover accessory "detached" from the mcs instrument during removal from the cannula and fell inside the patient. The tip cover was retrieved laparoscopically. The mcs instrument with the tip cover accessory installed was in use for less than 20 minutes. The tip cover was inspected prior to use and did not make any contact with other instruments or hard material during the surgical procedure. The planned surgical procedure was completed and no patient harm, adverse outcome or injury was reported.
 
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Brand NameENDOSCOPIC ELECTROSURGICAL INSTRUMENT
Type of DeviceTIP COVER ACCESSORY
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
950 kifer rd.
sunnyvale
Manufacturer Contact
tabitha reed
950 kifer rd.
sunnyvale 
4085232100
MDR Report Key7645885
MDR Text Key112861159
Report Number2955842-2018-10331
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeKR
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 06/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400180-14
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/25/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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