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U.S. Department of Health and Human Services

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

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INTUITIVE SURGICAL, INC ENDOWRIST PROGRASP FORCEPS Back to Search Results
Model Number 470093-11
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2021
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the 8mm prograsp forceps instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) replicated/ confirmed the customer reported complaint. Failure analysis found the primary finding of the grip pin workmanship issue to be related to the customer reported complaint. The 8mm prograsp forceps instrument was found to have a dislodged grip pin. The pin measured approximately 0. 073" x 0. 250" and was not returned. The grip did not exhibit any damage and the root cause of this failure is attributed to manufacturing. A review of the instrument log for the prograsp forceps (470093-11/n131907290109) associated with this event has been performed. Per logs, the prograsp forceps was last used on (b)(6) 2021 on system (b)(4). The alleged instrument had 1 use remaining after the last procedural use. A review of the site's complaint history found that there were no other complaints for this product. No image or video of the last procedure was provided for review. Based on the information provided at this time, this complaint is being reported based on the failure analysis findings. Failure analysis confirmed the prograsp forceps instrument's grip pin was dislodged with no evidence of user mishandling/misuse. This instrument is designed with a grip pin on the distal end allowing articulation of the instrument assemblies they are holding together and is secured to the device by swaging. If the pin is not properly fused together, the pin could become dislodged and fall into the patient. 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 during a da vinci-assisted surgical procedure, the 8mm prograsp forceps instrument did not grasp the tissue or clamp shut due to a loose tip. 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 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 Key13102342
MDR Text Key288671841
Report Number2955842-2021-11827
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
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 12/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470093-11
Device Catalogue Number470093
Device Lot NumberN13190729 0109
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/25/2019
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: 12/28/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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