• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTUITIVE SURGICAL, INC ENDOWRIST TIP-UP FENESTRATED GRASPER Back to Search Results
Model Number 470347-09
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/08/2021
Event Type  malfunction  
Manufacturer Narrative
The tip-up fenestrated grasper instrument has not been returned for evaluation. Therefore, failure analysis of the product related to the complaint cannot be performed. A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received. A review of the site's complaint history indicates that there is no other reportable events related to this product or event. A review of an instrument image that was provided is consistent with the alleged complaint of "piece of plastic fell off the instrument. " the root cause of the failure mode cannot be confirmed without the returned device. This complaint is being reported based on the following conclusion: it was alleged that a fragment from the tip-up fenestrated grasper instrument broke off and fell into the patient. The fragment was retrieved during the same procedure and no additional surgical intervention was required. However, unintended fragments falling into the patient may require surgical intervention. At this time, it is unknown what caused the breakage to occur. While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.
 
Event Description
It was reported that during a da vinci-assisted right lower pulmonary lobectomy surgical procedure, the customer noticed a piece of hard plastic in the patient's chest. This piece allegedly came from the tip-up fenestrated grasper. The instrument was retrieved during the same case and there was no harm to the patient. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up with the initial reporter on (b)(6) 2021 and obtained the following additional information: the isi csr was present during the procedure and confirmed that the surgeon noticed a piece of plastic in the patient's chest. The surgeon was able to retrieve the fragment with a grasper through the laparoscopic/assist port. There was no instrument collision reported. The procedure was completed robotically with no report of patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENDOWRIST
Type of DeviceTIP-UP FENESTRATED GRASPER
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key12272044
MDR Text Key267654711
Report Number2955842-2021-10899
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 company representative,other
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 07/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470347-09
Device Catalogue Number470347
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

-
-