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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST FORCE BIPOLAR

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INTUITIVE SURGICAL, INC ENDOWRIST FORCE BIPOLAR Back to Search Results
Model Number 470405-06
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted paraoesophageal hernia surgical procedure, wispy tissue got caught in the crevice of the force bipolar instrument, where the cables can be seen. The surgeon used another robotic instrument to pull out the tissue and resumed the procedure without any further issue. The customer noted that there was no harm to the patient. The procedure was completed with no reported injury. The following additional information was obtained about the complaint through follow-up: the customer confirmed that there was no harm to the patient. Tissue and a suture got caught in the crevice of the instrument. The customer noted that pictures were taken. A request has been made for copies of the pictures, but they have not yet been received as of the date of this report. No further information was available. Additional follow-up was attempted with the surgeon. However, as of the date of this report, no response has been received.
 
Manufacturer Narrative
The force bipolar instrument has not been returned for device evaluation. As a result, the root cause of the reported issue has not been identified. A follow-up mdr will be submitted if the product is returned and analyzed and/or if additional information related to the event is received. A review of the site's complaint history revealed that there were no other complaints for this event. An instrument log review was performed. Per the review, the following was confirmed: the paraoesophageal hiatal hernia procedure was on (b)(6) 2022 on system (b)(4). The force bipolar instrument was last used on (b)(6) 2022 and it had 0 lives remaining. This complaint is considered to be a reportable event due to the following conclusion: it was reported that tissue got caught in the instrument's crevice. Medical intervention may be required in the event that a moving instrument mechanism within an instrument entraps tissue and causes damage. At this time, it is unknown what caused the device entrapment issue 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.
 
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Brand NameENDOWRIST
Type of DeviceFORCE BIPOLAR
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
izabel nielson
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key14132115
MDR Text Key289432094
Report Number2955842-2022-11108
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180351
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 03/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470405-06
Device Catalogue Number470405
Device Lot NumberN10200831 0085
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 04/17/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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