• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

INTUITIVE SURGICAL, INC ENDOWRIST PROGRASP FORCEPS Back to Search Results
Model Number 471093-11
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/08/2021
Event Type  malfunction  
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the instrument involved with this complaint and completed the device evaluation. Failure analysis (fa) investigation confirmed the reported failure of "issue with cable or pin". Failure analysis found the prograsp forcep's grip pin was missing at the distal end. The pin was not returned with the instrument. The root cause of the missing grip pin is typically attributed to manufacturing. A review of the instrument log for the product associated with this event shows that the prograsp forceps were last used on the reported event date of (b)(6) 2021 on system (b)(4). There was no indication that the instrument was used in subsequent procedures after the alleged event reported on this record. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. The alleged event occurred with 13 uses remaining on the instrument. No image or video clip for the reported event was submitted for review. Based on the information provided at this time, this complaint is being reported due to the following conclusion: failure analysis confirmed the instrument's grip pin was missing 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 that prior to the start of a da vinci-assisted surgical procedure, an issue was noted with the prograsp forceps. The customer noted that they were "not sure if it is a cable or pins". The procedure was reportedly completed with no patient injury. Intuitive surgical, inc. (isi) made multiple follow-up attempts to obtain additional information related to the reported event. However, no further details have been obtained as of the date of this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
david wang
3410 central expressway
santa clara, CA 
4085232100
MDR Report Key12381313
MDR Text Key268661723
Report Number2955842-2021-11025
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 Other Health Care Professional
Remedial Action Other
Type of Report Initial
Report Date 08/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2021
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 NumberN10200831 0111
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/27/2020
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

-
-