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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 Problems Thermal Decomposition of Device (1071); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2022
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the fenestrated bipolar forceps (fbf) instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) investigations did not replicate nor confirm the customer reported complaint. When the fbf instrument was placed and driven on an in-house system, the fbf instrument passed the recognition and engagement tests. The fbf instrument moved intuitively with full range of motion in all directions. The grips/tips opened and closed properly. The bumper test was performed and passed. As part of investigation, further investigation was performed. Unrelated issues were identified. First, found a frayed grip cable at the distal idler pulley. The frayed cable strands were stuck out at the wrist. Second, confirmed damage to the conductor wire¿s insulation. As a result, internal wires were exposed. The root cause of both failure are attributed to a component failure. Third, found thermal damage on the bipolar yaw pulley. The bipolar yaw pulley exhibits localized melting damage at the base of one of the grip tips. Electrical continuity was performed and passed. The root cause of this failure is attributed to mishandling and misuse. Last, found various scratch marks removed on the main tube. The scratch marks were 0. 135¿ - 0. 256¿ in length and were not aligned with the tube axis. The root cause of scratch marks /abrasions instrument main tube is typically attributed to mishandling/misuse. No image or video clip for the reported event was available for review. A review of the instrument log for the fenestrated bipolar forceps instrument (part# 471205-17/lot# n10210316-0057) associated with this event has been performed. Per logs, the instrument was last used for a pancreatoduodenectomy procedure on (b)(6) 2022 using system (b)(4). The instrument had 2 remaining usable lives with no subsequent use recorded. This complaint is considered a reportable event due to the following conclusion: the instrument had conductor wire damage. The damaged/broken conductor wire has potential for electrical discharge at a location other than intended. 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. Field is blank because the product is not implantable. Information for the blank fields is not available. Fields are not applicable.
 
Event Description
It was reported that during a da vinci-assisted pancreatoduodenectomy surgical procedure, the fenestrated bipolar forceps (fbf) instrument was observed to have not moved when using the master controls. A backup instrument of the same kind was used, and the procedure was completed with no reported injury. Intuitive surgical, inc. (isi) followed up and obtained the following additional information: the fbf instrument was inspected prior to use and no damage was observed. The customer confirmed no arcing was observed and the monopolar cord was not connected to the bipolar instrument. At the time of the event, the operating room team was using the erbe generator. The fbf instrument tips did not collide with any other instrument during procedure nor did the fbf instrument touch any staples, clips or sutures while energized. The jaws were not immersed in liquid or contaminated by carbonized tissue (bio debris) prior to activating the fbf instrument. The customer confirmed there was no patient injury. No further information was 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 Key15036605
MDR Text Key296040837
Report Number2955842-2022-13004
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874119808
UDI-Public(01)00886874119808(10)N10210316
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K131861
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 06/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471205-17
Device Catalogue Number471205
Device Lot NumberN10210316 0057
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2022
Date Manufacturer Received06/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2021
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: 07/16/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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