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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 470205-17
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2022
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the fenestrated bipolar forceps instrument involved with this complaint and completed the device evaluation. Failure analysis investigations did not replicate nor confirm the customer reported complaint. The instrument was placed and driven on an in-house system. The instrument passed the recognition and engagement tests on multiple attempts. The instrument moved intuitively with full range of motion in all directions. The grips opened and closed properly. The instrument was retested and passed all testing on both attempts. The housing was removed for inspection and there was no damage found on the instrument identification board. The instrument was fully functional. The logs were unavailable at this time. Additionally, the instrument was found to have a life indicator with a failure to rotate. The housing was removed and found the life indicator did not rotate when the instrument expired. The instrument logs were unavailable at this time. The instrument was placed on an in-house system and showed the instrument had 0 use remaining. The root cause is not established. Upon visual inspection, the instrument was found to have thermal damage on the bipolar yaw pulley at the distal end. Both sides of the bipolar yaw pulley exhibited localized melting. No conductor wire insulation damage was observed on the instrument. The electrical continuity test was performed and passed. The root cause is typically attributed to mishandling/misuse. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. The system was not connected to on site, and the instrument was not registered on the system. Therefore, an instrument log review of the product related to the complaint cannot be performed at this time. Review of the images revealed no obvious damage on fenestrated bipolar forceps instrument. Based on the additional information obtained from failure analysis investigation, this complaint is being reported due to the following conclusion: the instrument was found to have thermal damage on the bipolar yaw pulley at the distal end. Both sides of the bipolar yaw pulley exhibited localized melting. No conductor wire insulation damage was observed. At this time, it is unknown what caused the thermal damage 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. Blank mdr fields: follow-up was attempted, but the patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. Implant date is blank because the product is not implantable. Pma/510(k) number and adverse event are not applicable.
 
Event Description
It was reported that prior to the start (post-anesthesia and after port placement) of a da vinci-assisted nephrectomy surgical procedure, the fenestrated bipolar forceps instrument was not being recognized after installation and showing a yellow indicator. The customer reseated the fenestrated bipolar forceps instrument and completed the procedure with no reported injury. Intuitive surgical, inc. (isi) performed follow-up and obtained the following additional information regarding the reported event: the instrument was reportedly inspected prior to use, and no issues were noted. The issue was discovered after the customer inserted the instrument. No arcing or instrument collision were observed during the surgical procedure. A video recording of the procedure is not available, but images of the instrument were provided.
 
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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 Key14254856
MDR Text Key290441593
Report Number2955842-2022-11344
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470205-17
Device Catalogue Number470205
Device Lot NumberN11210503 0038
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/29/2021
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: 04/29/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES.
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