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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 471093-11
Device Problems Break (1069); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/04/2022
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted cholecystectomy surgical procedure, the prograsp forceps was not working properly. The procedure was completed with no reported injury. The prograsp forceps is a multiple-use endoscopic instrument with a grasping tip to be used in conjunction with the da vinci system. The instrument is designed to grab, manipulate, retract, and dissect tissue during a da vinci assisted surgical procedure. Intuitive surgical, inc. (isi) completed customer follow-up and obtained the following information: the customer confirmed the instrument was not working properly and there was no report of any fragments falling into the patient. The site completed the procedure and there was no patient injury nor has the patient returned to the hospital due to post-surgery complications.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the prograsp forceps instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) did not replicate nor confirm the reported issue as the instrument passed in house testing and the instrument fully functioned without issue. However, fa found the main tube broken from the instrument. A piece measuring approximately 0. 32¿ x 0. 103¿ was not returned. Fa attributed the root cause of the broken main tube to the user. 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 device logs for the prograsp forceps (part# 471093-11 | lot-sequence# k10210607 0079) has been performed. Per this review of the logs, the prograsp forceps was last used on 19-nov-2021 on system sk4200. The alleged event occurred on the 14th use of the instrument. The instrument has 18 total uses. No image or video of the procedure was provided for review. This complaint is considered a reportable event due to the following conclusion: failure analysis acknowledges 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 the 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 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 Key13657118
MDR Text Key296701035
Report Number2955842-2022-10442
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,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 02/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471093-11
Device Catalogue Number471093
Device Lot NumberK10210607 0079
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2021
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: 03/02/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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