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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST LARGE SUTURE CUT NEEDLE DRIVER

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INTUITIVE SURGICAL, INC ENDOWRIST LARGE SUTURE CUT NEEDLE DRIVER Back to Search Results
Model Number 471296-07
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2021
Event Type  malfunction  
Manufacturer Narrative
An rma has been issued to the customer requesting to have the large suturecut needle driver instrument returned; however, isi has not received the rma to confirm/identify any reportable failure mode(s). A follow-up mdr will be submitted if additional information is received. A review of the instrument log for the large suturecut needle driver instrument (471296-07/n10201123) associated with this event has been performed. Per the logs, the instrument was last used on (b)(6) 2021. A review of the provided image is consistent with the alleged complaint of a fragment falling into the patient and being retrieved. The root cause of the failure mode cannot be confirmed without the returned device. A review of the site's complaint history does not show any additional complaints related to this product. This complaint is being reported based on the following conclusion: it was reported that a fragment fell into the patient. The fragment was retrieved and no additional surgical intervention was required. However, unintended fragments falling into the patient may require surgical intervention. At this time, it is unknown what caused the breakage 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.
 
Event Description
It was reported that during a da vinci-assisted hysterectomy surgical procedure, while suturing, the instruments collided causing one side of the tip of the large suturecut needle driver instrument to fall into the patient. The customer had to use fluoroscopy to find the tip, but the tip was retrieved and the patient was not harmed. The procedure was completed with no reported 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.
 
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Brand NameENDOWRIST
Type of DeviceLARGE SUTURE CUT NEEDLE DRIVER
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
david wang
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key11721771
MDR Text Key267880315
Report Number2955842-2021-10435
Device Sequence Number1
Product Code NAY
UDI-Device Identifier00886874121504
UDI-Public(01)00886874121504(10)N10201123
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 company representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 03/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471296-07
Device Catalogue Number471296
Device Lot NumberN10201123 0028
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/20/2020
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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