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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 470049-07
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2022
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the cadiere forceps instrument involved with this complaint and completed the device evaluation. Failure analysis investigations replicated/confirmed the customer reported complaint. Failure analysis found the primary finding of the broken grip tip to be related to the customer reported complaint. The instrument was found to have a broken grip at the grip base. A piece, measuring approximately 0. 212" x 0. 641", was found to be broken off. The broken piece was not returned with the instrument. The cause of the ¿broken instrument grips ¿tips¿ is indicative of excess force applied to the instrument jaws. 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 submitted image was performed by an intuitive surgical, inc. (isi) regulatory post market surveillance (rpms) analyst. The following additional information was provided: the image of the cadiere forceps instrument identified that the instrument grip tip was detached. A review of the instrument log for the cadiere forceps instrument lot# n11200224 / sequence 0020 associated with this event has been performed. Per logs, the instrument was last used for a procedure on (b)(6) 2021 using system (b)(4). No logged usage on the reported event date of (b)(6) 2022. The instrument has 3 remaining usable lives with no subsequent use recorded. This complaint is considered a reportable malfunction due to the following conclusion: failure analysis investigations found that a piece was missing from the distal end of the instrument. The missing piece could fall inside the patient during the surgical procedure. While there was no reported harm or injury to the patient, and it was noted that no fragment fell inside the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur as unintended fragment(s) falling inside the patient may require surgical intervention.
 
Event Description
It was reported that during a da vinci-assisted pulmonary lobectomy surgical procedure, the customer discovered the front end of the cadiere forceps instrument was broken while grasping tissue. There was no report of any fragments falling inside the patient. The customer replaced the cadiere forceps instrument with a back-up instrument of the same kind and completed the procedure with no reported injury.
 
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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 Key13779690
MDR Text Key296999719
Report Number2955842-2022-10625
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K150284
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 02/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470049-07
Device Catalogue Number470049
Device Lot NumberN11200224 0020
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2022
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2020
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

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