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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. ENDOWRIST ONE VESSEL SEALER ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

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INTUITIVE SURGICAL,INC. ENDOWRIST ONE VESSEL SEALER ENDOSCOPIC ELECTROSURGICAL INSTRUMENT Back to Search Results
Model Number 410322-05
Device Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 12/11/2017
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the instrument involved with this complaint and completed investigations. Failure analysis was unable to confirm the customer reported complaint. Visual inspection did not find physical damage to the instrument and there were no instrument pieces found to be missing. The instrument's limit switch was found to be dislodged, as a result the instrument failed homing and the blade became dislodged. The blade was dislodged 0. 180. The limit switch was placed back in position and the instrument installed on an in-house system passed homing. Cut and seal functionality testing passed without an issue. Review of the instrument's logs found that 5 homing failures had occurred. Failure analysis investigations also found that the instrument's snake wrist was dislodged. It was concluded that the damage to the instrument's wrist was due to mishandling/misuse. No other damage was found. Based on the failure analysis investigation results, this mdr report is being retracted as it was determined that no fragment from the returned affected instrument fell into the patient and there were no missing instrument's components found to be missing from the instrument.
 
Manufacturer Narrative
The vessel sealer instrument has not been returned for evaluation; therefore, the root cause of the customer reported failure mode cannot be determined. A follow-up mdr will be submitted if the instrument is returned (post failure analysis) or if additional information is received. Isi has conducted a device history record (dhr) review for this device and did not find any non-conformances that were related to the reported event. Based on the information provided, this complaint is being reported due to the following conclusion: during a da vinci assisted surgical procedure, it was alleged that the vessel sealer instrument broke and a piece from the instrument fell into the patient. While the broken instrument piece was retrieved from the patient and there was no report of any patient harm, recurrence of the reported failure mode could likely cause or contribute to an adverse event. It is unknown what caused the instrument to break.
 
Event Description
It was reported that during a da vinci assisted surgical procedure, the vessel sealer instrument broke and a piece from the instrument fell into the patient. The broken instrument piece was retrieved. On (b)(6) 2018 intuitive surgical, inc. (isi) received additional information regarding the reported event from the site's robotics coordinator, who initially reported this complaint. According to the robotics coordinator, she was not present for the surgical procedure. She was told that during a da vinci assisted ventral hernia repair procedure, an unspecified piece broke off of the vessel sealer instrument and fell into the patient. The broken instrument piece was laparoscopically retrieved from the patient. It is unknown how long the instrument was in use prior to the instrument breakage issue. The instrument did not make contact with any other instrument during the surgical procedure and there was no observation that any lateral pressure was placed on the instrument while it was being used during the surgical procedure. The target tissue at the time of instrument breakage is unknown. There is no video recording and the surgeon does not know what may have caused or contributed to the broken instrument issue. According to the robotics coordinator, the planned surgical procedure was completed with a replacement vessel sealer instrument. There was no patient harm, adverse outcome or injury as a result of the instrument breakage issue.
 
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Brand NameENDOWRIST ONE VESSEL SEALER
Type of DeviceENDOSCOPIC ELECTROSURGICAL INSTRUMENT
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 Key7170833
MDR Text Key158782663
Report Number2955842-2018-00011
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110639
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/12/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number410322-05
Device Lot NumberM11161007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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