MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. GREEN ENDOWRIST STAPLERRELOAD; ENDOSCOPIC INSTRUMENT ACCESSORY

Model Number 48445G

Device Problem Malposition of Device (2616)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2017

Event Type  Injury  

Manufacturer Narrative

The green stapler reload was not returned to isi for failure analysis evaluation; therefore, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if the instrument is returned (post engineering evaluation) or if additional information is received.This complaint is being reported due to the following conclusion: during a da vinci assisted surgical procedure, the surgeon observed malformed staples after firing the stapler 45 instrument with a green stapler reload installed, requiring the surgeon to suture the patient's tissue.It is unknown what caused or contributed to the malformed staples issue.

Event Description

It was reported that during a da vinci assisted surgical procedure, during use of the stapler 45 instrument, the surgeon observed that the staples in the patient's bronchus were malformed.The surgeon made the decision to suture the patient's bronchus.On 06-19-2017, additional information regarding the reported event was provided by the intuitive surgical, inc.(isi) specialty sales representative (ssr) who initially reported this complaint.According to the ssr the planned surgical procedure was a da vinci assisted pulmonary lobectomy procedure.After transecting the patient's bronchus tissue using the stapler 45 instrument with a green stapler reload installed, the surgeon observed malformed staples.The ssr indicated that the affected tissue thickness appeared to be normal and the surgeon was able to obtain an adequate clamp.The ssr indicated that it is unknown if the patient had undergone any radiation or chemotherapy treatments.During use of the instrument, there were no issues noted.The surgeon does not know what caused the malformed staples issues.On 06-21-2017 the ssr provided photograph images of the affected green stapler reload and the affected tissue.Review of the photographs found that the photograph of the affected tissue was quite blurry.There was no observation of the photograph that showed anything that would have contributed to the malformed staples issue experienced by the surgeon.Review of the photograph of the affected green stapler reload showed that there were a couple of pushers towards the reload's proximal end that appeared to be lower than the rest of the pushers; however, review of the photograph was unable to confirm if the affected pushers were never fully deployed, or if they properly deployed, and then fell down after completion of the stapler 45 instrument's firing sequence.

• Brand Name: GREEN ENDOWRIST STAPLERRELOAD
• Type of Device: ENDOSCOPIC INSTRUMENT ACCESSORY
• 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: 6688400
• MDR Text Key: 79119384
• Report Number: 2955842-2017-00424
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113706
• 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: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 48445G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2017
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention