• 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 FORCE BIPOLAR

  • 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 FORCE BIPOLAR Back to Search Results
Model Number 471405
Device Problem Entrapment of Device (1212)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 04/01/2022
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, the cause of the customer reported failure mode and operative complication cannot be determined. The customer informed the isi csa that they plan to reprocess this force bipolar instrument to continue using it as they do not believe there is a malfunction of the product. A follow-up mdr will be submitted if additional information is obtained. A review of the system and instrument logs for this event has been performed and the following was observed: no relevant errors were observed during this procedure. This force bipolar instrument has not been reused in subsequent procedures. The customer has not created any product returns for this instrument. A video of this event was provided and reviewed by an isi post market surveillance specialist: the video is a total of eight seconds long and captures a video playing on a monitor. The video on the monitor shows the surgeon's view of the surgical field. The force bipolar instrument has tissue stuck in it's wrist. The force bipolar instrument is pulled away from the tissue, tearing most of the tissue. A strand of tissue is left stuck in the force bipolar wrist and a monopolar curved scissors (mcs) instrument is used to cut this strand. This complaint is being reported due to the following conclusion: during a da vinci-assisted inguinal hernia procedure, the wrist of the force bipolar instrument was catching peritoneal flap tissue. As a result, the surgeon excised the stuck tissue and sutured the tissue location. The cause of the customer reported failure mode and operative complication is unknown.
 
Event Description
It was reported that during a da vinci-assisted inguinal hernia procedure, the wrist of the force bipolar instrument was catching the peritoneal flap. The procedure was completed robotically. An intuitive surgical inc. (isi) clinical sales associate (csa) who was present during the procedure was contacted and additional information was obtained about the event: in this case, there was peritoneal tissue stuck in the wrist of the force bipolar instrument which required the surgeon to cut in order to remove the instrument. The excision site was sutured due to this event. There was no bleeding nor any negative impact to the patient. This resulted in a delay of 10 minutes. Isi contacted the surgeon of this procedure and additional information was obtained about the complaint: this event occurred while the surgeon was dissecting the inguinal hernia. The surgeon excised the stuck peritoneum tissue and then sutured the tissue location. No other intervention was performed due to this event. This event did not cause any bleeding. The surgeon reported this event impacted the procedure by adding more time to suture the location and it did not have any effect on the patient¿s health. The patient did not experience any post-operative issues and is doing well. The surgeon believes this event was caused by the force bipolar instrument as they said ¿the gears¿ on the wrist of the force bipolar instrument caught onto the tissue. The surgeon is unsure if this instrument is available for return.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameENDOWRIST
Type of DeviceFORCE BIPOLAR
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 Key14254925
MDR Text Key290447918
Report Number2955842-2022-11345
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180351
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Non-Healthcare Professional
Remedial Action Other
Type of Report Initial
Report Date 04/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471405
Device Catalogue Number471405
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/29/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
-
-