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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST TIP-UP FENESTRATED GRASPER

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INTUITIVE SURGICAL, INC ENDOWRIST TIP-UP FENESTRATED GRASPER Back to Search Results
Model Number 470347-09
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 02/07/2018
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the instrument involved with the complaint and completed the device evaluation. Failure analysis confirmed the customer reported failure mode. The instrument was found to have a broken pitch cable at the distal clevis hub. The broken cable segment that contains the crimp was missing from the clevis. The clevis did not exhibit any damage or wear marks. Other cables at the wrist were not damaged. A device history record (dhr) review for the device involved with the complaint has been completed. No non-conformances were identified to be related to this complaint. This complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that a fragment broke off and fell inside the patient. The broken fragment was retrieved without patient harm, adverse outcome or injury. Furthermore, failure analysis confirmed a broken pitch cable on the tip-up fenestrated grasper instrument. A broken pitch cable could cause or contribute to an adverse event if the failure mode were to recur.
 
Event Description
It was reported that during a da vinci-assisted hemicolectomy (right) procedure, the surgeon stated that the tip-up fenestrated grasper instrument was not working properly. The staff noticed a broken cable on the instrument. Later in the procedure, a piece of cable was found inside the patient and was retrieved by the surgeon using a different instrument. There was no report of patient harm, adverse outcome, or injury. Intuitive surgical, inc. (isi) made a follow up attempt and obtained the following additional information: the broken piece retrieved from the patient was discarded and was not returned with the instrument.
 
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Brand NameENDOWRIST
Type of DeviceTIP-UP FENESTRATED GRASPER
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 Key7317354
MDR Text Key101862618
Report Number2955842-2018-10038
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Patient
Type of Report Initial
Report Date 02/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470347-09
Device Lot NumberN10170525 0109
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/15/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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