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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 Discolored (1170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2022
Event Type  malfunction  
Event Description
It was reported that during central processing, the fenestrated bipolar forceps instrument pulleys were partially discolored. There was no report of patient involvement. Intuitive surgical, inc. (isi) followed up with the doctor of respiratory department and obtained the following additional information: the instrument was inspected prior to use and no abnormalities or damage were found. The damage was inspected by a cleaning staff during central reprocessing. Discoloration of the pulley cover was noted. The instrument did not collide with any other instrument or tool during the procedure. There was no arcing observed during the procedure.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the fenestrated bipolar forceps involved with this complaint and completed the device evaluation. Failure analysis investigations replicated and confirmed the customer reported complaint. Failure analysis found the primary failure of bipolar yaw pulley thermal damage to be related to the customer reported complaint. For clarification, the instrument was found to have 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. No damage to the conductor wire was observed. The root cause of this failure is attributed to mishandling/misuse. A review of the device logs for the fenestrated bipolar forceps (part# 471205-17 | lot/serial# n102107120-309) associated with this event has been performed. Per this review of the logs, the fenestrated bipolar forceps was last used on (b)(6) 2022 via system serial# (b)(4). There were 11 uses remaining after this last usage. No image or video clip for the reported event was available for review. This complaint is being reported based on the following conclusion: it was alleged that the fenestrated bipolar forceps instrument exhibited signs indicative of thermal damage. Failure analysis confirmed thermal damage to the bipolar yaw pulley. The root cause of this failure is attributed to user mishandling and misuse. 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 missing 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.
 
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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 Key15033506
MDR Text Key296040798
Report Number2955842-2022-12969
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874119808
UDI-Public(01)00886874119808(10)N10210712
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 06/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2022
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 NumberN10210712 0309
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2022
Date Manufacturer Received06/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2021
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: 07/15/2022 Patient Sequence Number: 1
Treatment
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