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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST FENESTRATED BIPOLAR FORCEPS

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INTUITIVE SURGICAL, INC ENDOWRIST FENESTRATED BIPOLAR FORCEPS Back to Search Results
Model Number 471205-17
Device Problem Difficult to Remove (1528)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 01/27/2022
Event Type  Injury  
Manufacturer Narrative
Isi field service engineer (fse) investigation has been completed. The fse followed up with the customer and asked if she was able to observe how the instrument was stuck. The customer informed fse the issue was the fenestrated bipolar instrument. They tried another instrument on arm #2 with no issues. When they tried with the original instrument, it got stuck again. The fenestrated bipolar instrument has been removed from circulation by the customer. Fse asked the customer if the release buttons on instrument were not working and the customer confirmed that they were not and it required them to manually release it. Issue was confirmed to be related to the instrument and not the system. The tse reviewed the site¿s system logs. No related system errors were found to have occurred during the surgical procedure. No image or video recording was available for review. This complaint is reportable due to the following: during the procedure, there was no energy from the fenestrated bipolar instrument. As a result, the customer attempted to swap the fenestrated bipolar instrument; however, the staff could not remove the device from the arm. As the there was a bleed that needed to be addressed immediately, the surgeon converted the procedure to a laparoscopic procedure. On a field evaluation it was confirmed that the issue was with the instrument and not the system arms. Since the instrument has not been returned to isi for evaluation, the cause of the reported issue is unknown.
 
Event Description
It was reported that during a da vinci-assisted myomectomy surgical procedure, there was no energy from the fenestrated bipolar instrument. Intuitive surgical, inc. (isi) contacted the surgeon and the site's robotics coordinator and obtained the following information regarding the reported event: during the initial phase of the procedure, during dissection of the uterus, the surgeon used the fenestrated bipolar for coagulation. However, there was no energy delivered. As a result, the customer attempted to swap the fenestrated bipolar instrument; however, the staff could not remove the device from the arm. The system did not generate any messages, and she was informed that they would have to restart the system. Although there was no significant bleeding, she wanted to address the bleed immediately. The patient had a bleeding disorder and was on a blood thinner. In addition, before the procedure, the anesthesiologist had administered a heparin shot. Hence, she did not want to wait and call an isi technical support engineer (tse) for assistance or use the fourth arm. She was comfortable converting the procedure to laparoscopic surgery. After the conversion, the bleeding was addressed by cauterization. The surgeon confirmed the patient is reported to be recovering well with no issues. The fenestrated bipolar instrument on arm #2 was undocked with the instrument still attached. Tse assisted the caller with removing the stuck instrument from arm #2. The robotics coordinator stated that even if there were a video recording of a procedure, they would not provide a copy for review. She also mentioned that it was determined that this fenestrated bipolar instrument was an issue in a previous surgery and should not have been in circulation after reprocessing. She could not provide additional details regarding that. The tse recommended that the site label this instrument not for use and return it to isi. However, it was stated that it was unlikely they would return the instrument.
 
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Brand NameENDOWRIST
Type of DeviceFENESTRATED BIPOLAR FORCEPS
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 Key13609265
MDR Text Key290932983
Report Number2955842-2022-10373
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 Other,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 01/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471205-17
Device Catalogue Number471205
Device Lot NumberK11211129 0156
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/25/2021
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: 02/26/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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