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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
Device Problem Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/29/2017
Event Type  malfunction  
Manufacturer Narrative
The tip cover accessory was discarded by the site and will not be returned to isi for evaluation. Therefore, the root cause of the customer reported failure mode cannot be determined. If additional information is received, a follow-up mdr will be submitted. This complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, the tip cover accessory fell inside the patient and was retrieved during the same da vinci procedure. However, at this time, the root cause of the customer reported failure mode is unknown.
 
Event Description
It was reported that during a da vinci-assisted myomectomy procedure, while using the monopolar curved scissor instrument with the tip cover accessory installed, the tip cover accessory fell off the instrument and into the patient. Additionally, the instrument shaft distal was found to be fractured. The tip cover accessory was retrieved from the patient. There was no report of patient harm, adverse outcome or injury. On 10/23/2017, intuitive surgical, inc. (isi) received the following additional information from the customer: the tip cover accessory was retrieved during the same da vinci procedure and was prior to the case being converted to open due to the patient's anatomy. The surgeon was working on the right side of the pelvis, his left arm was deflecting tissue leftward, but it was the right arm that stopped moving. The technician then pulled the instrument and it was noticed that the sheath had opened. When the tech tried to remove the instrument, the open sheath prevented it from coming through. Furthermore, no intra-operative collisions were observed. The tip cover accessory was discarded and will not be returned to isi for failure analysis.
 
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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 Key6973096
MDR Text Key90753279
Report Number2955842-2017-00709
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 09/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number400180
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 Received09/29/2017
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 Initial

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