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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI MARYLAND BIPOLAR FORCEPS

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INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI MARYLAND BIPOLAR FORCEPS Back to Search Results
Model Number 420172-17
Device Problems Thermal Decomposition of Device (1071); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2021
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted radical prostatectomy surgical procedure, the bipolar energy was not working on the maryland bipolar forceps instrument. The procedure was completed with no reported injury. Intuitive surgical, inc. (isi) obtained the following information from the customer about the complaint: firstly this instrument was billed to (b)(6) hospital, however, (b)(6) hospital need a maryland bipolar forceps instrument immediately so (b)(6) hospital gave (b)(6) hospital the instrument to use. The maryland bipolar forceps instrument did not work so they returned the instrument back to (b)(6) hospital. For this reason, a new bill to (b)(6) hospital was not prepared. The instrument belonged to (b)(6) hospital. We wrote (b)(6) hospital for both incidents because of this reason.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the maryland bipolar forceps instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) investigations confirmed the reported complaint. For clarification, the instrument failed the electrical continuity test because of a broken conductor wire at the bipolar insert junction of the back-end of the instrument. As a result, energy activation would not work when activated on the system. Root cause of broken conductor wire is attributed to a manufacturing and component issue. Additional observation fa found related to the reported complaint: thermal damage was observed at the bipolar insert junction where it connected with the conductor wire which was found broken off. Root cause of thermal damage of bipolar insert was not established. Black char marks were observed. Additional observation fa found that was not related to the reported complaint: signs of corrosion/contamination were found on the instrument bearings upon housing removal. Input disk bearings exhibit brownish-orange discoloration. Improper cleaning during reprocessing most commonly causes this failure. Signs of excessive residue were found on the instrument clamping pulleys upon housing removal. Improper cleaning during reprocessing most commonly causes this failure. No images or videos were shared for the event. A review of the device logs for the maryland bipolar forceps (part# 420172-17 | lot# n10210705-053) associated with this event has been performed. Per this review of the logs, the maryland bipolar forceps was last used on (b)(6) 2021 via system (b)(4). There were 8 uses remaining after this last usage. This complaint is considered a reportable event due to the following conclusion: failure analysis found the maryland bipolar forceps 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.
 
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Brand NameENDOWRIST;DAVINCI SI
Type of DeviceMARYLAND 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 Key15033028
MDR Text Key296040922
Report Number2955842-2022-12975
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874111475
UDI-Public(01)00886874111475(10)N10210705
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K050369
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,Followup
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 Number420172-17
Device Catalogue Number420172
Device Lot NumberN10210705 053
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/09/2022
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2021
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
DA VINCI INSTRUMENTS AND ACCESSORIES
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