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


  • 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

Model Number 471093-11
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/12/2021
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted hysterectomy-benign surgical procedure, the prograsp forceps instrument lost the grip on the tissue and it could not be articulated. The instrument was removed from the patient and it was inspected on the table. During the inspection, the pin that was holding the distal hinge fell out. The pin was inspected and found to be missing the flange at one end of the pin. The surgeon inspected the patient¿s abdominal cavity and performed an x-ray with no fragments/foreign bodies detected. The customer used a backup instrument and the procedure was completed with no reported patient injury. Intuitive surgical, inc. (isi) followed up with the initial reporter (nurse) and obtained additional information: no fragments fell into the patient¿s cavity. The pin fell out during the inspection on the table and it was put back on the instrument for failure analysis. Abdominal and pelvic x-rays were performed and found no fragment in the patient. Failure of the flange on the hinge pin was believed to be cause of the instrument breakage. The reported issue happened when the surgeon was grasping onto the remnants of cervix tissue. The instrument was used for approximately 45-60 minutes. The surgeon did not notice any issues with the functionality of the instrument during the surgical procedure. The instrument did not collide with any other instruments or other hard material. When the instrument was removed, the jaws were noted to be misaligned.
Manufacturer Narrative
The prograsp forceps instrument was received and failure analysis testing was performed and the customer reported issue was confirmed. The instrument was found to have the grip pin dislodged at the distal end. As a result, the grips were not secured properly at the grip assembly. The grip pin, approximately 0. 23" x 0. 07" was returned with the instrument and no material appeared to be missing. The root cause of dislodged instrument grip pin is attributed to manufacturing. A review of the site's complaint history does not reveal any additional complaints involving this product and/or this event. Review of the provided images are consistent with the reported complaint and the failure analysis findings of loose pin and misaligned/dislodged jaws. A review of the instrument log for the prograsp forceps instrument (part number: 471093-11, lot number: k10210324 0106) associated with this event has been performed. Per logs, the instrument was last used on (b)(6) 2021 on system sk1920. The instrument was used for 10 minutes. The instrument had 8 uses remaining out of 18 max tool uses. This complaint is considered a reportable malfunction due to the following conclusion: it was alleged that a pin was dislodged from the instrument and the flange on the pin was missing during a da vinci assisted procedure 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. Blank mdr fields: relevant tests and patient medical history for fields were unknown. The expiration date for section is not applicable. Field is blank because the product is not implantable. Field is blank because it is unknown if the initial reporter submitted a report to the fda. Fields are not applicable.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
3410 central expressway
santa clara CA
Manufacturer (Section G)
3410 central expressway
santa clara CA
Manufacturer Contact
izabel nielson
3410 central expressway
santa clara, CA 
MDR Report Key12981693
MDR Text Key285472436
Report Number2955842-2021-11725
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 11/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2021
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 NumberK10210324 0106
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/24/2021
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: 12/12/2021 Patient Sequence Number: 1