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

Model Number 470298-12

Device Problem Difficult to Remove (1528)

Patient Problem Abscess (1690)

Event Date 09/18/2019

Event Type  Injury  

Manufacturer Narrative

4315.Based on the current information provided, the root cause of the patient¿s post-operative complication cannot be determined.Intuitive has received the stapler 45 instrument associated with this complaint and completed investigations.Failure analysis investigations confirmed the customer reported complaint that the stapler instrument could not be removed properly.Review of system logs showed that a stapler reload was fired completely but the user clamped again, and then attempted to remove the stapler instrument without unclamping.As a result, the stapler is in a clamped state and cannot open up the grip housing while outside the system arm without using the stapler release kit (srk).The standard clinical workflow following a completed fire is for the system to automatically unclamp, which should reflect in the logs as two shift events (shifting from fire to roll, then from roll to clamp) followed by an unclamp event.Review of system logs showed that after the last completed firing event with this instrument, the two expected shift events appear, along with an unexpected clamp event, and two "unknown state" events.The system logs show a non-recoverable error 26002 occurring at the same time as the unexpected clamp and unknown state events.Error 26002 details indicate an execution of a clamp command failed.Since the error 26002 is non-recoverable, the user would have had to use the srk to manually unclamp the jaws, which is mentioned in the complaint.The system logs also show evidence of e-stop button presses following the error 26002.E-stop press is the first step in srk instructions.An additional observation not reported was a broken grip cable at the wrist.Intuitive motion was not being experienced upon manual input of the disk knobs.The broken cable segment that contains the crimp was missing from its slot.The missing crimp was approximately 0.046¿ x 0.032.¿ any potential fragments would have been retained by the stapler sheath.A follow-up mdr will be submitted if additional information is received.Isi has reviewed the site¿s system logs with a procedure date of (b)(6) 2019.No related system errors were found to have occurred during the surgical procedure.This complaint is being reported due to the following: after undergoing a da vinci-assisted surgical procedure, the patient experienced a post-operative abscess that was treated conservatively.At this time, the root cause of the post-operative complication is unknown.It is unclear if the post-operative complication is even related to the stapling issue experienced by the surgical staff.

Event Description

It was initially reported that during a da vinci-assisted low anterior resection procedure, the stapler 45 instrument was unable to be removed after it was fired.The stapler release kit (srk) was used to remove the instrument.There were no fragments that fell inside of the patient's anatomy.The procedure was completed with a delay of approximately 30 minutes with no adverse effect or injury to the patient.Per the site, the associated reload was discarded and will not be returned for evaluation.On (b)(6) 2019, intuitive surgical, inc.(isi) contacted the initial reporter and obtained the following additional information regarding the reported event: the surgical procedure was not recorded on video.The instrument was inspected prior to use.At the time the event occurred, the initial reporter believed the surgeon was ¿trying to close the jaws.¿ the target tissue was rectum.There was no tissue tension or tissue bundles.In addition, the target tissue was not exposed to any prior radiation or chemotherapy.While using the stapler 45 instrument, the surgeon had encountered obstacles which were staples.The surgical procedure was not completed with a replacement stapler instrument.Post-operatively, the patient developed an ¿abscess formation on the rectum that was treated conservatively.¿ in regards to the patient¿s current condition, the patient was noted to be ¿doing well.¿.

Manufacturer Narrative

On 11/26/2019, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: after the stapling issue occurred, the surgical or resection margin was inspected and found to be completely closed.Therefore, no other stapler instruments were used to complete the surgical procedure.In regards to the post-operative complication, the abscess was incised with the patient under general anesthesia.In addition, local irrigation was performed.The surgeon or site believes the post-operative abscess formation was caused by ulcerative colitis, a long operating time, and a stapler defect.Based on the current information provided, this complaint will remain reportable due to the following conclusion: after undergoing a da vinci-assisted surgical procedure, the patient experienced a post-operative abscess that required additional medical intervention.The surgeon or site claimed that the post-operative abscess might have been caused by a stapler defect.

• Brand Name: ENDOWRIST
• Type of Device: STAPLER 45
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA 95051
• MDR Report Key: 9329749
• MDR Text Key: 166743779
• Report Number: 2955842-2019-10900
• 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: foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 470298-12
• Device Lot Number: T10181016 0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Initial Date Manufacturer Received: 10/21/2019
• Initial Date FDA Received: 11/15/2019
• Supplement Dates Manufacturer Received: 11/26/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Required Intervention