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

Model Number 470298-11

Device Problems Device Issue (2379); Difficult to Open or Close (2921)

Patient Problem Tissue Damage (2104)

Event Date 04/20/2018

Event Type  Injury  

Manufacturer Narrative

The instrument has not been returned for 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 failure analysis evaluation) or if additional information is received.The site¿s system logs with a procedure date of (b)(6) 2018 were reviewed.The system logs reveal that the stapler 45 instrument successfully fired 4 reloads (2 white and 2 blue) before a shifting failure occurred while clamped.A shifting failure would prompt the user to use the srk.The system logs show that a total of 3 estop presses were performed with the first occurring 3 minutes after the shifting failure.Based on the information provided at this time, this complaint is being reported due to the following conclusion: during the da vinci-assisted surgical procedure, the surgeon transected tissue around the jaws of the stapler 45 instrument which were allegedly stuck grasping bowel tissue.However, at this time, the root cause of the customer reported failure mode is unknown.

Event Description

It was reported that during the da vinci-assisted right hemicolectomy procedure, the jaws of the stapler 45 instrument got stuck while clamped down on small bowel tissue.The intuitive surgical, inc.(isi) clinical sales representative (csr), who was present during the case, contacted an isi technical support engineer (tse) for support.The csr indicated that the stapler release kit (srk) broke off in the instrument.The surgical staff was able to remove the broken piece from the instrument.The surgical staff then attempted unsuccessfully to open the jaws of the instrument using two separate instrument release kits (irk).The tse informed the csr that alternate surgical intervention would need to be discussed with the surgeon.On 24-apr-2018, isi contacted the csr and obtained the following information regarding the reported event: the csr could not confirm the lot number of the stapler 45 instrument involved with the reported event.According to the csr, the surgeon was able to fire the stapler 45 instrument about 2-4 times during the procedure and before the event occurred.The csr stated that at the time the event occurred, a system error was generated which instructed the user to use a srk to remove the instrument.At that time, he was doing something else in the or and was unaware that the surgical staff was already trying to open the jaws of the stapler 45 instrument with the srk.By the time he was aware of the event, the srk had already broke while in hole #1 of the stapler 45 instrument.The surgical staff had not pressed the estop button prior to attempting to use the srk.After pressing the estop button and removing the srk fragment that was stuck in hole #1, the surgical staff attempted unsuccessfully to use a irk to open the instrument's jaws.In order to remove the stapler 45 instrument, the surgeon used another stapler 45 instrument and transected small bowel tissue on both sides of where the initial stapler 45 instrument was stuck on tissue.The surgeon was able to complete the surgical procedure robotically using the backup stapler 45 instrument.No post-operative complications have been reported to his knowledge.

Manufacturer Narrative

The stapler 45 instrument was returned for evaluation.Failure analysis confirmed the customer reported complaint that the stapler instrument misfired while being used.For clarification, a blue stapler 45 reload was returned stuck on the stapler 45 instrument.Review of the site¿s system logs showed that this stapler instrument was used at the site on 04/20/2018 with system sk0099 and struggled to complete a clamp after several attempts.Eventually, the stapler 45 instrument was able to fully clamp, but the stapler instrument was removed in a hard clamp mode, leading to the stapler 45 reload being stuck in the grip housing of the stapler.No firing of the reload was attempted.The hard clamp mode event coincides with a shifting failure in relation to the stapler 45 instrument.As noted on the initial mdr, a shifting failure occurred while the stapler instrument was clamped and a shifting failure would prompt the user to use the stapler release kit (srk).The instrument was placed on an in-house system.No initialization failures or errors/faults were replicated during in-house testing.Clamp and fire tests passed.No physical damage was found at the instrument¿s wrist.Based on the additional information provided, this complaint will remain reported due to the following conclusion: during the da vinci-assisted surgical procedure, the surgeon transected tissue around the jaws of the stapler 45 instrument which were allegedly stuck grasping bowel tissue.However, at this time, the root cause of the customer reported failure mode is still unknown.

• Brand Name: ENDOWRIST
• Type of Device: STAPLER 45
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7526208
• MDR Text Key: 108669640
• Report Number: 2955842-2018-10213
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874112427
• UDI-Public: (01)00886874112427(10)T12180214
• 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
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• 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: T12180214 0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Date Manufacturer Received: 05/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES; DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Outcome(s): Required Intervention