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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 Problem Use of Device Problem (1670)
Patient Problem Injury (2348)
Event Date 06/16/2018
Event Type  Injury  
Manufacturer Narrative
Isi has not received the tip-up fenestrated grasper instrument involved with this complaint. A review of the site¿s system logs reveal that the instrument has been used in two subsequent da vinci-assisted surgical procedures. A review of the site¿s complaint history reveal that no subsequent complaints involving the instrument have been reported to isi. No related system errors were found to have occurred during the surgical procedure. Based on the information provided at this time, this complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted pulmonary lobectomy procedure, the patient experienced a post-operative ¿air leak. ¿ the surgeon claimed that the post-operative complication was possibly caused by the wrist area of the tip-up fenestrated bipolar forceps instrument. However, the root cause of the post-operative complication is unknown.
 
Event Description
It was initially reported that during the da vinci-assisted pulmonary lobectomy procedure, the wrist of the tip-up fenestrated grasper instrument allegedly caused an air leak. On 22-jun-2018, intuitive surgical, inc. (isi) contacted the isi specialty sales manager (ssm) and the following additional information regarding the reported event was obtained: the ssm was not present during the case. However, the surgeon informed her of the event. The surgeon claimed that during the procedure, lung parenchyma got caught around the wrist area of a tip-up fenestrated grasper instrument. It is unknown how the surgeon was able to free the tissue. The surgical procedure was completed robotically. The surgeon reportedly explained that with any pulmonary lobectomy procedure, chest tubes were placed post-operatively. However, an "air leak" was identified post-operatively and the chest tubes remained in the patient longer than anticipated. The patient was expected to be discharged from the hospital on (b)(6) 2018; however, due to the air leak, the patient was hospitalized for a longer period of time. The surgeon claimed that the air leak was possibly caused by the tip-up fenestrated grasper instrument since lung tissue had gotten stuck in the instrument's wrist area. On 22-jun-2018, isi also contacted isi sales manager and the following additional information regarding the reported event was obtained: he was present during the case which was not recorded on video. The sales manager indicated that when the event occurred, the surgeon showed him the image of the lung tissue stuck on the instrument¿s wrist. The surgeon was able to free the tissue by straightening the instrument¿s wrist. No tissue damage or bleeding was observed upon freeing the tissue from the instrument¿s wrist. The surgical procedure was completed robotically.
 
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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 road
sunnyvale CA 94086
Manufacturer Contact
tabitha reed
950 kifer road
sunnyvale, CA 94086
4085232100
MDR Report Key7681996
MDR Text Key113786204
Report Number2955842-2018-10367
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
Reporter Occupation
Type of Report Initial
Report Date 06/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number470347-09
Device Lot NumberN10171106 0119
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/12/2018 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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