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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL,INC. TIP-UP FENESTRATED GRASPER Back to Search Results
Model Number 470347
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/03/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The instrument has not be 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, it was alleged that broken fragments fell inside the patient. Although, the broken fragments were retrieved without patient harm, at this time it is unknown what caused the breakage to occur.
 
Event Description
It was reported that during a da vinci-assisted sigmoid colectomy procedure, as the surgeon was getting ready to convert the procedure to laparoscopy, the tip-up fenestrated grasper instrument could not be removed from the cannula accessory as it could not be straightened out. The surgeon observed a broken piece of the instrument shaft on the bowel and frayed wires. The robotics coordinator was then called into the room and was unable to remove the instrument without completely breaking the instrument. The shaft of the instrument was falling apart in her hand and she placed the pieces in a cup for evaluation. According to the surgeon, all pieces were removed. There was no report of patient harm, adverse outcome or injury. On (b)(6) 2018, intuitive surgical, inc. (isi) made a follow-up attempt to obtain additional information; however, the customer could not release any other information. Furthermore, it was confirmed that the instrument was sequestered and that it was stuck in a 8mm cannula accessory and could not be removed without breaking the instrument completely.
 
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Brand NameTIP-UP FENESTRATED GRASPER
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 Key7227232
MDR Text Key98973641
Report Number2955842-2018-00064
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 health professional
Reporter Occupation
Type of Report Initial
Report Date 01/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470347
Device Lot NumberN10170508
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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