MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; TIP-UP FENESTRATED GRASPER

Model Number 470347-09

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 06/16/2018

Event Type  Injury  

Manufacturer Narrative

Isi has not received the tip-up fenestrated grasper instrument involved with this complaint.A review of the site¿s system logs reveal that the instrument has been used in two subsequent da vinci-assisted surgical procedures.A review of the site¿s complaint history reveal that no subsequent complaints involving the instrument have been reported to isi.No related system errors were found to have occurred during the surgical procedure.Based on the information provided at this time, this complaint is being reported due to the following conclusion: after undergoing a da vinci-assisted pulmonary lobectomy procedure, the patient experienced a post-operative ¿air leak.¿ the surgeon claimed that the post-operative complication was possibly caused by the wrist area of the tip-up fenestrated bipolar forceps instrument.However, the root cause of the post-operative complication is unknown.

Event Description

It was initially reported that during the da vinci-assisted pulmonary lobectomy procedure, the wrist of the tip-up fenestrated grasper instrument allegedly caused an air leak.On 22-jun-2018, intuitive surgical, inc.(isi) contacted the isi specialty sales manager (ssm) and the following additional information regarding the reported event was obtained: the ssm was not present during the case.However, the surgeon informed her of the event.The surgeon claimed that during the procedure, lung parenchyma got caught around the wrist area of a tip-up fenestrated grasper instrument.It is unknown how the surgeon was able to free the tissue.The surgical procedure was completed robotically.The surgeon reportedly explained that with any pulmonary lobectomy procedure, chest tubes were placed post-operatively.However, an "air leak" was identified post-operatively and the chest tubes remained in the patient longer than anticipated.The patient was expected to be discharged from the hospital on (b)(6) 2018; however, due to the air leak, the patient was hospitalized for a longer period of time.The surgeon claimed that the air leak was possibly caused by the tip-up fenestrated grasper instrument since lung tissue had gotten stuck in the instrument's wrist area.On 22-jun-2018, isi also contacted isi sales manager and the following additional information regarding the reported event was obtained: he was present during the case which was not recorded on video.The sales manager indicated that when the event occurred, the surgeon showed him the image of the lung tissue stuck on the instrument¿s wrist.The surgeon was able to free the tissue by straightening the instrument¿s wrist.No tissue damage or bleeding was observed upon freeing the tissue from the instrument¿s wrist.The surgical procedure was completed robotically.

• Brand Name: ENDOWRIST
• Type of Device: TIP-UP FENESTRATED GRASPER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 950 kifer road; sunnyvale CA 94086
• Manufacturer Contact: tabitha reed ; 950 kifer road; sunnyvale, CA 94086 ; 4085232100
• MDR Report Key: 7681996
• MDR Text Key: 113786204
• Report Number: 2955842-2018-10367
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112496
• UDI-Public: (01)00886874112496(10)N10171106
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 470347-09
• Device Lot Number: N10171106 0119
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2017
• 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
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Hospitalization; Required Intervention