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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 Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2022
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) has received the fenestrated bipolar forceps instrument involved in this case and failure analysis (fa) testing has been performed. Fa was able to confirm the reported complaint. The instrument was found to have thermal damage on the bipolar yaw pulley. The instrument passed the electrical continuity test. The instrument was placed on the in-house system and successfully received and delivered energy. No damage was found on conductor wire. Root cause of this failure is attributed to mishandling/misuse no image or video clip for the reported event was available for review. A review of the instrument logs showed the fenestrated bipolar forceps instrument (part# 471205-17 / lot# k12211213-0036) was last used on (b)(6) 2022 during a radical prostatectomy with lymphadenectomy procedure with system (b)(4). The fenestrated bipolar forceps instrument had 5 uses remaining. This last usage of the device was before the reported central processing event date. This complaint is being reported due to the following conclusion: it was alleged that the fenestrated bipolar forceps instrument exhibited signs indicative of thermal damage. At this time, 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 central processing, the plastic at the tip of the fenestrated bipolar forceps was found burnt. There was no report of patient involvement. Intuitive surgical, inc. (isi) followed up with the nurse and obtained the following additional information: since this instrument was not used on june 14, it seems the instrument should be below that was used on (b)(6). The initial report was incorrect, the damage was noted during cleaning after the procedure. The thermal damage occurred during the last procedure. There was no anomaly observed at inspection prior to use. It was unknown if arcing was observed during last usage. There was no injury to the patient.
 
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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 Key15036915
MDR Text Key296040861
Report Number2955842-2022-13026
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874119808
UDI-Public(01)00886874119808(10)K12211213
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 06/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2022
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 NumberK12211213 0036
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2022
Date Manufacturer Received06/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2021
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: 07/17/2022 Patient Sequence Number: 1
Treatment
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