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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 Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2022
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted unilateral inguinal hernia surgical procedure, the tip of the force bipolar instrument was dislodged and the instrument was stuck inside the port. No fragment fell inside the patient. The procedure was completed with no reported patient injury. Intuitive surgical, inc. (isi) followed up with the initial reporter and obtained additional information: the instrument was inspected prior to use with no damage noted. The or staff was able to straighten the jaws and remove the instrument from the cannula. The jaws were not stuck on the tissue. A backup instrument was used to complete the procedure with no reported patient injury.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the instrument involved with this complaint and completed the device evaluation. Failure analysis did not confirm/replicate the reported complaint. The instrument was placed and driven on an in-house system. The instrument passed the recognition and engagement tests. The instrument moved intuitively with full range of motion in all directions. The grips opened and closed properly. The instrument was fully functional. Visual inspection of the instrument found no physical or cosmetic damage on the distal end. The housing was removed from the back end, and no damage was found. The instrument was installed and removed from the in-house system several times and did not experience any difficulty or resistance when removing. An electrical continuity test was performed and passed. Grip management and energy delivery tests were performed while the instrument was installed on an in-house system and passed. There was no problem detected. A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event. A review of the instrument log for the force bipolar instrument (part number: 471405-06, lot number: k12211122-0189) associated with this event has been performed. Per logs, the instrument was last used on (b)(6) 2022 on system sk2737. The instrument was used for 17 minutes. The instrument had 7 uses remaining out of 12 maximum tool uses. No image or video clip for the reported event was submitted for review. This complaint is considered as a reportable event due to the following conclusion: it was alleged that the force bipolar instrument could not be removed from the cannula due to the grip tip sticking out/jaw being dislodged. Jaw dislodgment could result in the tips being stuck and unable to be opened with mtm activation or instrument release kit (irk) use. 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 while grasping tissue. Medical intervention may be required in the event that the instrument jaws fail to open from tissue when commanded by the user or system.
 
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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 Key14227526
MDR Text Key290472566
Report Number2955842-2022-11266
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 Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 03/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2022
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 NumberK12211122 0189
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2022
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2021
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: 04/27/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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