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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST MARYLAND BIPOLAR FORCEPS Back to Search Results
Model Number 471172-16
Device Problem Thermal Decomposition of Device (1071)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2022
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) confirmed the reported complaint of "burnt rubber at the tip". The instrument was found to have thermal damage on the bipolar yaw pulley. The yaw pulley showed signs of charring and localized melting at the base of the grip on their exterior. The thermal damage to the yaw pulley is unrelated to the conductor wire on this instrument. No insulation damage was observed. The conductor wire is not damaged or broken. An electrical continuity test was performed and passed. The root cause for this failure is attributed to user mishandling misuse, commonly caused by collision with another energized instrument. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. A review of the instrument log for the maryland bipolar forceps (part# 471172-16 / lot# n11200622/ sequence# (b)(4)) associated with this event has been performed. Per this review of the logs, the instrument was last used on (b)(6) 2022 on system serial# (b)(4) with 2 uses remaining. Based on this review, the instrument was not used in the reported event date or in any subsequent procedure(s) after its last used. There was no image or video clip submitted for review. Field implant date is blank because the product is not implantable.
 
Event Description
It was reported that prior to the start of a da vinci-assisted surgical procedure, the maryland bipolar forceps had burnt rubber at the tip. The procedure was completed with no reported injury. There was no patient involvement.
 
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Brand NameENDOWRIST
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 Key14257864
MDR Text Key290476306
Report Number2955842-2022-11368
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 03/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471172-16
Device Catalogue Number471172
Device Lot NumberN11200622
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/12/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2020
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: 05/02/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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