MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST VESSEL SEALER EXTEND

Model Number 480422-01

Device Problems Failure to Deliver Energy (1211); Entrapment of Device (1212)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, the cause of the customer reported failure modes cannot be determined. Isi has received the vse instrument used during this event; however, as of the date of this report, the failure analysis investigation has not been completed. A follow-up mdr will be submitted if additional information is obtained. The vse instrument logs were reviewed by an isi failure analysis engineer (fae). Per the fae, the logs showed no errors were logged during this procedure. A system logs review was performed for this procedure: no relevant errors were observed during this procedure. This complaint is being reported due to the following conclusion: during a da vinci-assisted total colectomy procedure, the vse instrument was insufficiently sealing tissue and the instrument jaws were sticking to tissue. The surgeon used an endoloop to control the bleeding. The cause of the customer reported failure modes is unknown. Blank mdr fields: follow-up was attempted, but the missing patient information was either unknown, unavailable, not provided, or not applicable. The expiration date is not applicable. 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 total colectomy procedure the vessel sealer extend (vse) instrument jaws were sticking to tissue. There was reportedly more tissue oozing than the surgeon expected. The vse instrument was removed and cleaned several times; the customer continued to use this instrument for this procedure. On 15-apr-2022, intuitive surgical inc. (isi) contacted the surgeon of this procedure and the following additional information was obtained about the complaint: the vse instrument was being used to divide mesentery as well as the vascular supply of the colon and rectum. The surgeon reported the colorectal mesentery and mesenteric vessels were damaged during this event. About 100cc¿s of blood was lost due to this event. According to the surgeon, she typically expects to lose about 25cc of blood during these tasks. The surgeon reported that the bleeding was occurring because the vse instrument was both insufficiently sealing tissue and also becoming stuck on sufficiently sealed tissue, damaging it and causing it to bleed. The surgeon stated that ¿sometimes it seemed that the tissue started bleeding as soon as the vessel sealer came off the tissue and other times it got stuck to the tissue and then bled a few minutes later. None of the bleeding was vigorous, but it was significant enough that required additional interventions more attempts at tissue sealing with the vessel sealer or using the endoloop to get the areas around the major named vessels (middle colic) to be hemostatic. ¿ the surgeon reported that this vse instrument worked as expected for about the first hour of the procedure, then these reported issues began. The surgeon reported hearing the seal complete tones as expected during this procedure. The seal completed tones were received just before releasing mesentery tissue that immediately bled. The surgeon did not know what electrical surgical unit (esu) was in use during this procedure. The surgeon reported using the endoloop to secure several vessels as intervention due to these events. The surgeon said these events affected the procedure by causing ¿significant delays¿ at about an hour. They surgeon said much of the mesentery they worked on during this event was in a total proctocolectomy. The surgeon reported these events will have no long-term impact on the patient who was recovered well with no post-operative complications. No blood transfusions were administered due to this event. The patient has been discharged. When asked what the surgeon thinks caused these events the following reply was received: ¿there was some tissue edema and inflammation in the pelvis from his ulcerative colitis, so that wasn't surprising but the rest of the proximal colon was normal without this and i still had this issue even though the tissue looked normal. ¿.

• Brand Name: ENDOWRIST
• Type of Device: VESSEL SEALER EXTEND
• 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 Key: 14255883
• MDR Text Key: 290529253
• Report Number: 2955842-2022-11349
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 480422-01
• Device Catalogue Number: 480422
• Device Lot Number: L91220130 0088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2022
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: ISIFA-2022-01-C

Patient Treatment Data

Date Received: 04/29/2022 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES.