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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 470405-06
Device Problems Entrapment of Device (1212); Insufficient Information (3190)
Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104); Unspecified Tissue Injury (4559)
Event Date 10/12/2020
Event Type  Injury  
Manufacturer Narrative
Based on the current information provided, the root cause of the customer reported failure mode cannot be determined or is unknown. If additional information is received, a follow-up mdr will be submitted. System error log review was conducted for procedure on (b)(6) 2020 on system sk3507. There were no observed events in the system logs that would suggest a product issue and logged events are in line with normal system functionality. A review of the instrument logs was performed for procedure on (b)(6) 2020 on system sk3507. Force bipolar instrument pn: 470405-06; ln: n10200803-0060 was on its tenth, and last use on (b)(6) 2020. While none of the instruments used in the procedure have been used in subsequent procedures at this time, a site history search shows no complaints filed against any of the instruments used, including the aforementioned force bipolar instrument. No image, or video clip for the reported event was submitted for review. Site history review was conducted on 14-oct-2020 and did not show any additional complaints related to this event. During a da vinci-assisted inguinal hernia repair procedure, tissue from the colon was caught in the wrist joint of a force bipolar instrument. As a result, the outer layer of colon wall, the serosal layer, tore, and was quickly repaired with one suture at the time the issue was observed. Placement of a clip, suture, staple, or other intervention that was not planned, to control bleeding of a vascular structure are considered, ¿medical intervention to preclude permanent impairment. " there was minimal to no additional blood loss and no blood transfusion was required. There were no wires observed protruding from the instrument. It was confirmed that strong grip mode was not being applied at the time of the issue. The procedure completed robotically. The patient¿s status was reportedly "good. " however, at this time, the root cause of the intra-operative complication is unknown. The product is not implantable. It is unknown if the initial reporter submitted a report to the fda.
 
Event Description
It was reported that during a da vinci-assisted inguinal hernia repair procedure, the outer layer of colon wall became caught in either the cable or joint of a force bipolar instrument. As a result, an injury occurred to the wall of the colon which was repaired with sutures. The procedure completed with no other report of injury. On 14-oct-2020 intuitive surgical, inc. (isi) obtained the following additional information regarding the reported event: during a da vinci-assisted inguinal hernia repair procedure, tissue from the colon was caught in the wrist joint of a force bipolar instrument. As a result, the outer layer of colon wall, the serosal layer, tore and was quickly repaired with one suture at the time the issue was observed. There was minimal to no additional blood loss and no blood transfusion was required. There were no wires sticking out of the instrument. It was observed by surgical staff present during the case that the surgeon used the shaft of the force bipolar instrument as a retractor of sorts; even near the instrument wrist itself. It was confirmed that strong grip mode was not being applied at the time of the issue. The procedure completed robotically with no other issues reported. The patient was reported as doing fine.
 
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Brand NameENDOWRIST
Type of DeviceFORCE BIPOLAR
Manufacturer (Section D)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer (Section G)
INTUITIVE SURGICAL, INC
3410 central expressway
santa clara CA 95051
Manufacturer Contact
david wang
3410 central expressway
santa clara, CA 95051
4085232100
MDR Report Key10805803
MDR Text Key215505309
Report Number2955842-2020-11176
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,Health Professional
Reporter Occupation Other Health Care Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 10/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number470405-06
Device Catalogue Number470405
Device Lot NumberN10200803 0060
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/30/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/06/2020 Patient Sequence Number: 1
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