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

Model Number 410322

Device Problem Failure to Deliver Energy (1211)

Patient Problem Injury (2348)

Event Date 12/14/2020

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.Full instrument and system details were not provided, so no system or instrument log review could be performed.No image or video clip for the reported event was submitted for review.The name of the hospital was not provided, so no search for related complaints could be performed.Based on the information provided at this time, this complaint is reportable due to the following: it was alleged that the patient sustained an unspecified injury based on the medwatch form field selections, but additional details of the injury and/or medical intervention required were not provided and follow-up is not possible as the site details are not known.At this time, the severity, additional event details, and steps taken to address an unspecified injury and unspecified medical intervention remain unknown and the root cause of the customer reported issue is unknown.

Event Description

On 12-jan-2021, intuitive surgical, inc.(isi) received medwatch mw5098539 stating: ¿vessel sealer not activating; connections and cords checked per guidance of intuitive surg mfr rep replaced with new instrument with no further issues.Lot: m90200310, exp: 2022-03-31¿.It was reported that during an unspecified da vinci-assisted surgical procedure, a vessel sealer (vs) instrument did not activate.The customer checked connections and cords and replaced the vessel sealer with a new instrument.No further issues were reported and the procedure continued, but an unspecified injury and medical intervention required was indicated on the medwatch form.Additional follow-up cannot be conducted due to lack of site and contact information.

• Brand Name: ENDOWRIST
• Type of Device: VESSEL SEALER
• 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: 11214885
• MDR Text Key: 228202914
• Report Number: 2955842-2021-10076
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 410322
• Device Catalogue Number: 410322
• Device Lot Number: M90200310
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Required Intervention