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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST FORCE BIPOLAR

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INTUITIVE SURGICAL, INC ENDOWRIST FORCE BIPOLAR Back to Search Results
Model Number 471405-06
Device Problem Entrapment of Device (1212)
Patient Problem Insufficient Information (4580)
Event Date 02/18/2022
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, the cause of the reported complication has been determined to be product related, however, the cause of the customer reported failure mode cannot be determined. The force bipolar instrument has not been returned to intuitive surgical, inc. (isi) for evaluation. If additional information is received, a follow-up mdr will be submitted. Logs confirmed that the force bipolar instruments have not been used in subsequent procedures. A review of instrument reports was performed and shows three force bipolar instruments were used in the component separation tar procedure. It is unknown which force bipolar instrument had the reported issue. Logs confirmed that the force bipolar instruments have not been used in subsequent procedures. The force bipolar (part # 471405-6; /lot # k10211018-0078) associated with this event has been performed. Per the logs, the instrument was last used on (b)(6) 2022 on system (b)(4). The alleged event occurred on the 1st use of the instrument. The force bipolar (part # 471405-6; / lot # k11210816-0156) associated with this event has been performed. Per the logs, the instrument was last used on (b)(6) 2022 on system (b)(4). The alleged event occurred on the 5th use of the instrument. The force bipolar (part # 471405-6; / lot # n11210621-0219) associated with this event has been performed. Per the logs, the instrument was last used on (b)(6) 2022 on system (b)(4). The alleged event occurred on the 11th use of the instrument. A review of the site's complaint history does not show any additional complaints related to this event no image or video clip for the reported event was submitted for review. This complaint is being reported due to the following conclusion: during a da vinci-assisted component separation surgical procedure, the wrist of the force bipolar was getting caught on tissue. The surgery continued robotically. No other information was provided. The cause of the customer reported failure mode is unknown.
 
Event Description
It was reported that during a da vinci-assisted component separation surgical procedure, the wrist of the force bipolar was getting caught on tissue. The surgery continued robotically. No other information was provided. Intuitive surgical, inc. (isi) has made multiple follow up attempts to obtain additional information concerning the reported event with no success.
 
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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 Key13865114
MDR Text Key293103709
Report Number2955842-2022-10721
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 02/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471405-06
Device Catalogue Number471405
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received02/21/2022
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: 03/23/2022 Patient Sequence Number: 1
Treatment
DA VINCI INSTRUMENTS AND ACCESSORIES
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