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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 06/30/2022
Event Type  malfunction  
Manufacturer Narrative
The fenestrated bipolar forceps instrument has not been returned for evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.A review of the instrument log for the fenestrated bipolar forceps (part# 471205-17 | lot# k10220418 0028) associated with this event has been performed.Per this review of the logs, the instrument was last used on (b)(6) 2022.No image or procedure video was provided for review.This complaint is being reported based on the following conclusion: it was alleged that the instrument exhibited signs indicative of thermal damage.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.Follow-up was attempted, but the missing 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 during central processing, the fenestrated bipolar forceps had a defective plastic insulation.The procedure was completed with no reported injury.The site also confirmed there were no fragments in the patient.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: there was no cable broken.The defective plastic isolation referred to a burn/damage at the extremity of the fenestrated bipolar forceps.A possible arcing from a monopolar curved scissors (mcs) may have happened, however it could not be confirmed.
 
Event Description
Refer to h10/h11 for follow-up information.
 
Manufacturer Narrative
Intuitive surgical, inc.(isi) has received the fenestrated bipolar forceps instrument associated with this complaint and completed investigations.Failure analysis investigations replicated/confirmed the customer reported complaint "defective plastic insulation." failure analysis found the primary failure of bipolar yaw pulley thermal damage to be related to the customer reported complaint.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.Root cause of this failure is attributed to mishandling/misuse.
 
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Brand Name
ENDOWRIST
Type of Device
FENESTRATED 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 Key15135308
MDR Text Key296942597
Report Number2955842-2022-13254
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874119808
UDI-Public(01)00886874119808(10)K10220418
Combination Product (y/n)N
Reporter Country CodeSZ
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,Followup
Report Date 07/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number471205-17
Device Catalogue Number471205
Device Lot NumberK10220418 0028
Was Device Available for Evaluation? Device Returned to Manufacturer
Initial Date Manufacturer Received 07/01/2022
Initial Date FDA Received07/29/2022
Supplement Dates Manufacturer Received09/22/2022
Supplement Dates FDA Received10/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/13/2022
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 Sequence Number1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES.
Patient Age62 YR
Patient SexMale
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