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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 471405-06
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2021
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted inguinal hernia repair surgical procedure, the patient's tissue got caught on the force bipolar instrument's wrist. The procedure was completed with no reported patient injury. Intuitive surgical, inc. (isi) followed up with the initial reporter (clinical sales representative) and obtained additional information: the instrument was inspected prior to use and no damages were noted. The surgeon was attempting to grasp the tissue when the reported issue occurred. There was no adverse effect to the stuck tissue and there was no unexpected tissue removal. There was no unexpected bleeding and there was no injury to the patient. No fragment fell inside the patient.
 
Manufacturer Narrative
The customer will not be returning the force bipolar instrument for intuitive surgical, inc. (isi) evaluation. Therefore, failure analysis of the product related to the complaint cannot be performed. A follow-up mdr will be submitted if additional information is received. A review of the site's complaint history does not reveal any additional complaints involving this product or this event. Verification of the event details and a system log review was not performed since there is insufficient or unconfirmed product/event information. Review of the provided images and video are consistent with the reported issue of stuck tissue on the instrument¿s wrist. The root cause of the failure mode cannot be confirmed without the returned device. This complaint is considered as a reportable malfunction due to the following conclusion: it was alleged that tissues were being caught on the force bipolar instrument¿s wrist with no evidence or claim of mishandling or misuse. Medical intervention may be required in the event that the tissue was caught on the instrument. At this time, it is unknown what caused the event 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 Key13026219
MDR Text Key289513461
Report Number2955842-2021-11763
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 11/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471405-06
Device Catalogue Number471405
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/14/2022
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 Reuse
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 12/17/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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