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

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.

Event Description

Refer to h10/h11 for follow-up information.

Manufacturer Narrative

Based on a re-evaluation of the complaint information, this complaint has been reclassified as an adverse event and product problem rather than just an adverse event as previously reported.Corrected information can be found the following fields: b1, h1, and h6.B1 updated from "adverse event" to "adverse event and product problem".H1 updated to "serious injury".H6 annex fields updated with coding for this event.

• Brand Name: ENDOWRIST
• Type of Device: FORCE 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 Key: 10805803
• MDR Text Key: 215505309
• Report Number: 2955842-2020-11176
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874115930
• UDI-Public: (01)00886874115930(10)N10200803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180351
• Number of Events Reported: 1
• 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 Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470405-06
• Device Catalogue Number: 470405
• Device Lot Number: N10200803 0060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES.
• Patient Outcome(s): Required Intervention