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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI PROGRASP FORCEPS Back to Search Results
Model Number 420093-14
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2021
Event Type  malfunction  
Manufacturer Narrative
The prograsp forceps instrument was requested to be returned, but it has not yet been received by isi for evaluation. Therefore the root cause of the customer reported failure mode cannot be determined. A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received. Review of the provided image is consistent with the grip pin loose / dislodged at the distal end. Root cause of the failure mode cannot be confirmed without the returned device. A review of the instrument log for the prograsp forceps instrument (pn# 420093-14 lot# n10201207-592) associated with this event has been performed. Per logs, the instrument was used on the reported event date of (b)(6) 2021 on system sh2338 for approximately 10 minutes. The alleged event occurred on the 1st use of the instrument. A review of the site's complaint history does not reveal any related or duplicate complaints involving this product and/or this event. This complaint is being reported due to the following conclusion: the instrument's pin was loose with no evidence or claim of user mishandling / misuse. 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 partial nephrectomy surgical procedure, the screw that holds the handle to the jaw of the prograsp forceps instrument had loosened. A backup instrument of the same type was used and 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;DAVINCI SI
Type of DevicePROGRASP 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 Key13085600
MDR Text Key286745126
Report Number2955842-2021-11811
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K050369
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 12/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420093-14
Device Catalogue Number420093
Device Lot NumberN10201207 592
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received03/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/03/2020
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: 12/26/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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