MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. 8 MM LARGE HEM-O-LOK CLIPAPPLIER; ENDOSCOPIC INSTRUMENT

Model Number 470230-09

Device Problem Device Issue (2379)

Patient Problems Tissue Damage (2104); Blood Loss (2597)

Event Date 08/11/2017

Event Type  Injury  

Manufacturer Narrative

Isi has not received the large hem-o-lok clip applier instrument or hem-o-lok clip involved with this complaint.Therefore, the root cause of the alleged customer reported failure mode is unknown.A follow-up mdr will be submitted if the instrument or hem-o-lok clip are returned (post failure analysis evaluation) or if additional information is received.This complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, the patient sustained a bigger tear injury to the pulmonary artery while the surgeon attempted unsuccessfully to place a hem-o-lok clip on the vessel.As a result of the vessel injury, the patient allegedly lost 2l of blood and 6 units of blood products were administered.In addition, to control the bleeding, the case was converted to open surgery where the patient experienced cardiac arrest.However, at this time, the root causes of the customer reported failure mode and intra-operative complications are unknown.

Event Description

It was initially reported that during a da vinci-assisted pulmonary lobectomy procedure, a small bleed was identified from the pulmonary artery.The surgeon used a cadiere forceps instrument in order to control the small bleed.While attempting to place a hem-o-lok clip on the pulmonary artery using a robotic clip applier instrument, the clip allegedly would not deploy.The surgeon believed that possibly the wrong type of clip was loaded on the robotic clip applier instrument.At that point, a bigger tear on the pulmonary artery was identified which resulted with huge bleeding.The case was emergently converted to open surgery and an instrument release kit (irk) was used on an unidentified instrument.During the conversion to open surgery, the patient reportedly suffered cardiac arrest.However, it was noted that the patient survived the surgery.On 08/18/2017, intuitive surgical, inc.(isi) contacted the surgeon and obtained the following information regarding the reported event: there was no allegation that a robotic instrument or accessory caused the initial small bleed from the pulmonary artery.However, the surgeon was uncertain as to what caused the small bleed.The surgeon confirmed that he used a cadiere forceps instrument to control the small bleed.He explained that when the bigger tear occurred, he was attempting to place a hem-o-lok clip on the pulmonary artery using an unspecified robotic clip applier instrument.The surgeon claimed that the clip wouldn't clip shut despite fully closing the master tool manipulator (mtm) on the surgeon side console (ssc).The surgeon was unsure if user-error was involved.He did not know if a correct clip was installed on the robotic clip applier instrument or if the clip was loaded correctly.In order to control and minimize the bleeding that resulted from the bigger tear, the surgeon attempted to use an unidentified robotic stapler instrument as a clamp on the vessel.Within a 15 second time period during the event, the patient reportedly lost approximately 2l of blood.The surgeon was unable to control the bleeding so the decision was made to convert to a thoracotomy procedure.The patient side cart (psc) was undocked from the patient while the unidentified robotic stapler was still left clamped on the pulmonary artery.After undocking the psc from the patient, the surgical staff attempted unsuccessfully to open the jaws of the unidentified robotic stapler instrument using a stapler release kit (srk).The surgical staff eventually removed the unidentified stapler instrument and the surgeon repaired the pulmonary artery using 3:0 proline sutures.The patient was given approximately 6 units of blood products and the pulmonary lobectomy procedure was completed via open surgery.According to the surgeon, the patient is alive and currently recovering.On 08/22/2017, isi received information from the site indicating that the unspecified robotic clip applier instrument was a large hem-o-lok clip applier instrument (part 470230-09; lot n10161117).In addition, the unidentified robotic stapler instrument was a curved-tip stapler 30 instrument (part 470530-05; lot s10161114).

Manufacturer Narrative

Intuitive surgical, inc.(isi) has received the hem-o-lok clip applier instrument involved with this complaint and completed investigations.Failure analysis did not confirm the customer reported complaint.Upon visual and microscopic inspection of the instrument, no damage was found to the clip applier assembly.No broken cables were observed at the instrument's wrist.Manual input of the disk knob exhibited intuitive motion.The instrument was placed on an in-house system.The instrument passed recognition and engagement on several attempts and on different arms.The instrument was driven and moved intuitively.The clip applier instrument opened and closed properly.Several attempts were made successfully to install ligation clips on the instrument's grips.Ligation clips were used to perform clip applier function properly with no trouble found with the jaws.Based on the current information provided, this complaint will remain reportable due to the following conclusion: during the da vinci-assisted surgical procedure, the patient sustained a bigger tear injury to the pulmonary artery while the surgeon attempted unsuccessfully to place a hem-o-lok clip on the vessel.As a result of the vessel injury, the patient allegedly lost 2l of blood and 6 units of blood products were administered.In addition, to control the bleeding, the case was converted to open surgery where the patient experienced cardiac arrest.However, at this time, the root causes of the customer reported failure mode and intra-operative complications are still unknown.The instrument was returned to isi, evaluated, and no trouble was found.

• Brand Name: 8 MM LARGE HEM-O-LOK CLIPAPPLIER
• Type of Device: ENDOSCOPIC 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: 6822546
• MDR Text Key: 83727090
• Report Number: 2955842-2017-00572
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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,Followup
• Report Date: 08/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 470230-09
• Device Lot Number: N10161117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention