MAUDE Adverse Event Report: INTUITIVE SURGICAL,INC. ENDOWRIST STAPLER 45; ENDOSCOPIC INSTRUMENT

Model Number 470298-11

Device Problems Nonstandard Device (1420); Device Displays Incorrect Message (2591); Mechanical Jam (2983)

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

Event Date 07/11/2016

Event Type  Injury  

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this event and failure analysis investigation has been completed.Removal of the instrument housing found that the roll bearing and proximal grip cable were broken.Disassembly of the instrument found that the tip of the srk was lodged in the manual shift cam and concluded that the wrench and backend grip cable breakage were likely a result of repeated unsuccessful attempts to unclamp.One half of the bearing was located at the bottom of the instrument chassis, in a location between the clamp lifter and tower.Positioning of bearing fragment acted as a spacer and caused the clamp lifter to disengage from the rest of the clamp drive train.The effect of the clamp lifter disengagement is the inability to for the instrument jaws to unclamp, even if the srk is used.Based on the information provided, this complaint is being reported due to the following conclusion: during a da vinci assisted sleeve gastrectomy procedure; the jaw of the stapler 45 instrument became stuck on the patient's tissue requiring the surgeon to transect tissue to remove the instrument.Failure analysis investigation found the instrument had a broken roll bearing which fell into the chassis of the instrument and prevented opening of the instrument jaws.

Event Description

It was reported that during a da vinci assisted sleeve gastrectomy procedure, the jaw of the stapler 45 instrument was closed on the patient's tissue and could not be released.The site attempted to use the stapler release kit (srk), power cycled the system and performed an emergency power off; however, the instrument jaws would not open.On (b)(6) 2016, intuitive surgical, inc.(isi) contacted the isi clinical sales representative (csr) whom stated that after the surgeon fired the stapler 45 instrument with a blue stapler reload installed and during the unclamping sequence, a system error message occurred stating instrument expired.According to the csr, this was the 8th fire from the instrument during the surgical procedure and the reported issue occurred while the surgeon was working near the pylorus section of the patient's stomach.The csr indicated that the surgeon transected the patient's tissue from around the jaw of the instrument to remove the instrument.The surgeon then converted the planned surgical procedure to traditional laparoscopic techniques to complete the transection and to complete the surgical procedure.No additional intervention was required and the patient was reported to be doing well post the procedure.

• Brand Name: ENDOWRIST STAPLER 45
• 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
• MDR Report Key: 5845307
• MDR Text Key: 51117441
• Report Number: 2955842-2016-00543
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• PMA/PMN Number: K140553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470298-11
• Device Lot Number: S10160427 0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2955842-071416-010-R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention