MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. MARYLAND BIPOLAR FORCEPS; ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

Model Number 420172-09

Device Problem Device Issue (2379)

Patient Problems Injury (2348); Blood Loss (2597)

Event Date 08/28/2017

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the patient's intra-operative complication is unknown.If additional information is received, a follow-up mdr will be submitted.Isi has reviewed the site's system logs with a procedure date of (b)(6) 2017.The system logs reveal that the maryland bipolar forceps instrument was used in a subsequent da vinci-assisted surgical procedure.No subsequent complaints have been reported to isi involving the instrument.No related system errors were found to have occurred during the surgical procedure.This complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, the initial reporter claimed that the maryland bipolar forceps instrument might have been a contributing factor to the intra-operative bleeding experienced by the patient.In order to control the bleeding, the da vinci-assisted surgical procedure was converted to open surgery and the patient was given blood transfusions.However, the root cause of the patient's intra-operative complication is unknown.

Event Description

It was initially reported that during a da vinci-assisted thymectomy procedure, a branch from an unspecified main artery in the pericardium was damaged.As a result, the surgical procedure was converted to open surgery in order to control bleeding that ensued.According to the initial reporter, the event occurred while the surgeon was performing exfoliation around the brachiocephalic vein.During this process, the surgeon was sealing unspecified tissue with an endowrist one vessel sealer instrument and a maryland bipolar forceps instrument was being used to hold aside tissue of the internal thoracic vein.At one point, bleeding was observed from the joint part of the maryland bipolar forceps instrument and the surgeon made the decision to convert to open surgery.A nurse indicated that the blood loss was approximately 1600 ml and the patient's blood pressure during the event was 38/10.After the case was converted to open surgery, it was determined that the source of the bleeding was a collateral vessel, originating from the great artery, that the surgeon was unaware of.The initial reporter indicated that the belief was that the vessel had ruptured for an unknown reason.The surgical procedure was completed via open surgery.The total estimated blood loss from the surgical procedure was 2000 ml and the patient had reportedly received transfusions.On 09/07/2017, intuitive surgical, inc.(isi) received the following information from a professor at the site: the site was unsure if the operative complications were related to the da vinci surgical system.The site believed that the operative complications could have been due to the shape of the maryland bipolar forceps instrument or the time it took to convert the da vinci surgical procedure to open surgery.The professor explained that it was the first time that the or staff had undergone an emergency conversion to open surgery.In addition, the professor mentioned that the or staff did not have enough experience with the emergency conversion to open surgery.In regards to the maryland bipolar forceps instrument, the professor described the instrument's tip as being slightly sharp and the bleeding started after the instrument was moved down towards the direction of the tissue.A cardiac surgeon was able to achieve hemostasis during the reported event and blood vessel suturing was performed.After the surgical procedure was completed via open surgery, the patient was admitted to the icu and eventually transferred to the regular hospital ward.The professor indicated that the patient underwent suture removal on an unclear date and was to be discharged on (b)(6) 2017.The professor further indicated that the patient recovered smoothly.

• Brand Name: MARYLAND BIPOLAR FORCEPS
• Type of Device: ENDOSCOPIC ELECTROSURGICAL INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL,INC.; sunnyvale CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC.,; 950 kifer rd; sunnyvale CA
• Manufacturer Contact: tabitha reed ; 950 kifer rd; sunnyvale, CA ; 4085232420
• MDR Report Key: 6884132
• MDR Text Key: 87188492
• Report Number: 2955842-2017-00621
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K050369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 420172-09
• Device Lot Number: N10140924-613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention