• 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 MARYLAND BIPOLAR 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 MARYLAND BIPOLAR FORCEPS Back to Search Results
Model Number 470172-16
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2020
Event Type  malfunction  
Event Description
It was reported that during a da vinci-assisted nephroureterectomy surgical procedure, the jaws of the maryland bipolar forceps was not working, so the patient side assistant removed the instrument and found that it was damaged. A fenestrated bipolar forceps instrument was used to complete the procedure with no reported injury. Intuitive surgical, inc. (isi) followed up with the customer and obtained the following additional information: it was confirmed there was no arcing witnessed, no injury, and the issue was that the jaws did not open properly.
 
Manufacturer Narrative
Intuitive surgical, inc. (isi) received the maryland bipolar forceps (mbf) instrument involved with this complaint and completed the device evaluation. Failure analysis confirmed and replicated the reported complaint. The primary failure of broken pitch cable was found to be related to the customer reported complaint. The mbf instrument was found to have a broken pitch cable at the distal clevis hub. The broken cable segment that contains the crimp was still installed in the clevis. As a result, non-intuitive motion could be observed. The pitch cable breakage occurs when the tensile load exceeds the ultimate strength of the material. The pitch cable construction is designed to optimize load and fatigue characteristics. Variation in customer use conditions, procedure type, patient anatomy, product handling, instrument tip length, grip torque, and manufacturing tolerances are a few variable, which could influence the pitch cable failure. The root cause of this failure is attributed to component failure. The instrument had 7 uses remaining. A log review was conducted, which resulted in the following findings: the logs show the customer last used the maryland bipolar forceps (mbf) instrument part# 470172-16 lot# t10190603-0079 on (b)(6) 2020 during a nephroureterectomy procedure with system sk1648. The instrument had 7 lives remaining. A review of the site's system logs for the reported procedure date was conducted. Investigation revealed there were no related system errors to have occurred during the surgical procedure that would have likely caused or contributed to the reported complaint. No image or video clip for the reported event was submitted for review. Based on the information provided, this event is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, it was alleged that the jaws of the maryland bipolar forceps instrument were not working. Per completed failure analysis, the instrument was found to have a broken pitch cable. If a pitch cable breaks at the distal end, a cable segment and/or the crimp could fall into the patient. While there was no report of any patient harm, adverse outcome or injury, recurrence of the reported failure mode could cause or contribute to an adverse event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENDOWRIST
Type of DeviceMARYLAND BIPOLAR 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 Key13117148
MDR Text Key290814275
Report Number2955842-2021-11833
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K131861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470172-16
Device Catalogue Number470172
Device Lot NumberT10190603 0079
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Date Manufacturer Received12/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2019
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: 12/30/2021 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
-
-