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

Model Number 480422-01

Device Problems Failure to Deliver Energy (1211); Retraction Problem (1536)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/11/2022

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the causes of the customer reported operative complication cannot be determined.Isi received the vse instrument associated with this event and completed investigations.The instrument was found to have dislodged blade based on log review, but was not observed during in-house inspection.No conductor wire or snake wrist damage was found.There was light bio debris found at the instrument tip.A review of logs showed one blade exposed failure (error 22025) indicating the"vessel sealer blade cannot retract." upon visual inspection, the jaw ceramic dots were visible and the knife slot measured at 0.027".The instrument was placed on an in-house system and passed self-test.The root cause of a dislodged instrument blade is typically attributed to the user.The cut and sealing tests were performed and the instrument passed both with no issues.A follow-up mdr will be submitted if additional information is obtained.The vessel sealer logs were reviewed by an isi advanced failure analysis (afa) engineer and the following findings were obtained: the system logs and e-100 generator logs were reviewed and there is one instance of the vse instrument (lot #l90220307-0333) failing to cut with the end result of the blade becoming jammed.The surgeon then switched to another vse (lot #l90220307-0334) which was used to complete the procedure with no errors.No image or video clips for the reported event were submitted by the customer for review.This complaint is being reported due to the following conclusion: during a da vinci-assisted sigmoid colectomy procedure, the surgeon encountered a bleeding vessel while working with a vse instrument.Another vse instrument was used to complete the case robotically.

Event Description

It was reported that during a da vinci-assisted sigmoid colectomy procedure, the surgeon encountered a blade exposed message and a bleeding vessel while working with the vessel sealer extend (vse) instrument.The customer was able to change out the vse instrument with a new one and correct the patient issues.In addition, the surgical staff proceeded with the case.There were no other reports of patient injury and the new, replacement vse instrument was reportedly working normal.Intuitive surgical, inc.(isi) received additional information about the complaint from the surgeon.The instrument was inspected prior to use and no damage was noted.The vse instrument was used twice with no issues during the procedure and before the event occurred.During the two uses of the vse instrument prior to when the event occurred, normal audible sealing tones were heard.The issue occurred during the third attempt to use the vse instrument, while the surgeon was cutting and dissecting meso-rectum, the target tissue.The error message ¿blade exposed¿ appeared and the vse instrument would not close or seal.No seal completed tones were heard during attempts to seal with the vse instrument.The meso-rectum was less than 7mm.There was no evidence of tissue calcification and the tissue appeared normal.The vse instrument did not come into contact with a clip, suture, staple, or other metal objects when the reported issue was noted and the jaws were not immersed in liquid.The vse instrument was also not contaminated by carbonized tissue (bio debris) prior to or during the sealing cycle.Blood loss of less than 50 ml was observed from the meso-rectum as a result of the vse instrument not sealing properly.No blood transfusion was given and there is no report of serious deterioration or clinical instability reported.No images or videos of the procedure were provided.In addition, no patient demographic information was provided.The vse instrument was taken by an isi representative for return for failure analysis evaluation.

• 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: 14643759
• MDR Text Key: 293629774
• Report Number: 2955842-2022-12084
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)L90220307
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422-01
• Device Catalogue Number: 480422
• Device Lot Number: L90220307 0333
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2022
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: ISIFA2022-01-C
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES