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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST CADIERE FORCEPS

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INTUITIVE SURGICAL, INC ENDOWRIST CADIERE FORCEPS Back to Search Results
Model Number 471049-07
Device Problems Break (1069); Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2022
Event Type  malfunction  
Event Description
It was reported that the cadiere forceps instrument had a broken or loose cable. There were no reports of patient injury. Intuitive surgical, inc. (isi) made multiple follow-up attempts to obtain additional information. However, no further details have been received as of the date of this report.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the cadiere forceps instrument involved with this complaint and completed the device evaluation. The failure analysis (fa) investigation did not replicate nor confirm the customer's reported complaint of a broken or loose cable. The instrument was found to have a broken grip at the grip base. A piece approximately 0. 21" x 0. 64" was found to be broken off of the yaw pulley. The broken piece was not returned. The root cause of broken instrument grips -tips is typically attribute to mishandling/misuse, such as excess force applied to the instrument jaws. The instrument was found to have various scratch marks, with light material removed, on the main tube. The scratch marks were 0. 096¿ - 0. 161" in length and were not aligned with the tube axis. The root cause of scratch marks /abrasions on instrument main tube is typically attributed to mishandling/misuse. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. No image or procedure video was provided for review. A log review was performed for the cadiere forceps instrument reported in this complaint (part #: 471049-07/n11200817 0240). Per the logs, instrument was last used on 19-jan-2022. The instrument had 1 use remaining and was not used for any subsequent procedures. This complaint is being reported due to the following conclusion: the instrument had scratches, with light material removed, on the main tube. Failure analysis also acknowledged that a fragment was missing from a portion of the device that enters the patient. Based on the information provided, there was no report from the customer that a fragment from the instrument fell into the patient during a procedure. While there was no report of harm or injury to the patient and no report of fragments falling into the patient, the reported failure mode could likely cause or contribute to an adverse event if the fragment(s) did fall into the patient.
 
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Brand NameENDOWRIST
Type of DeviceCADIERE 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 Key13699141
MDR Text Key296859554
Report Number2955842-2022-10539
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150284
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
Report Date 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471049-07
Device Catalogue Number471049
Device Lot NumberN11200817 0240
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2022
Date Manufacturer Received02/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/13/2020
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: 03/08/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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