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

Model Number 410298-11

Device Problem Device Issue (2379)

Patient Problem Failure to Anastomose (1028)

Event Date 05/03/2018

Event Type  Injury  

Manufacturer Narrative

Isi has received the stapler 45 instrument involved with this complaint in addition to four stapler 45 reloads.However, at this time the evaluation of the instrument and reloads has not been completed.An initial inspection of the instrument found no visible damage.Therefore, at this time, the root cause of the customer reported failure mode cannot be determined.A follow-up mdr will be submitted if additional information is received.The site also provided a video clip of the reported event.The video appears to show a blue stapler 45 reload fired along tissue.After the reload is fired and the instrument¿s jaws are opened, a hole appears in between the staple lines.The cause of the hole is unknown.The surgeon then used a scissor instrument to complete the transection between the staple lines.The video clip also revealed that the surgeon oversewed the staple line with sutures.However, at this time, the root cause of the customer reported issue cannot be determined based on a review of the video clip.The site¿s system logs with a procedure date of (b)(6) 2018 were reviewed.The system logs show that the stapler 45 instrument fired 6 blue reloads which were completed.There were no firing or clamping failures.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 stapler 45 instrument allegedly had an incomplete cut incident.As a result, the surgeon completed the staple line transection with a scissor instrument and oversewed the staple lines with sutures as a precaution.However, at this time, the root cause of the customer reported failure mode is unknown.

Event Description

It was initially reported that during a da vinci-assisted ileal conduit procedure, the stapler 45 instrument allegedly had a partial fire issue and the stapler blade was found to be off the track.As a result of the event, the initial reporter claimed that the ileal conduit was damaged.On (b)(6) 2018, intuitive surgical, inc.(isi) contacted the isi clinical sales representative (csr) and obtained the following additional information regarding the reported event: the reported event occurred during the 4th or 5th fire of the stapler 45 instrument.A blue stapler 45 reload was installed at the time.There were no reported error messages when the event occurred.The surgeon did not encounter any clamping issues prior to firing the instrument.According to the csr, the staple lines looked complete; however, it did not appear as though the blade of the stapler reload had cut.The csr indicated that there was a hole around the staple line but she was not sure if the hole was created before or during the time the stapler 45 instrument was fired.The csr indicated that the surgeon over-sewed the staple lines as a precaution due to the customer reported stapling issue.To her knowledge, the surgeon completed the surgical procedure robotically but used a hand-held stapler instrument for the remainder of the procedure.No post-operative complications have been reported.On (b)(6) 2018, the site contacted isi to return the stapler 45 instrument.The surgeon had reportedly indicated that the anastomosis was compromised.The site indicated that the surgeon could not fire another stapler across the top because it would narrow the conduit too much.The remaining three fires were performed with a hand-held laparoscopic stapler instrument.

Manufacturer Narrative

The stapler 45 instrument was returned for evaluation.The instrument was installed on an in-house system and moved intuitively.No physical damage was observed on the wrist components.A shim test was performed using a metal reload and 0.032" shim to assess clamp performance.The shim test passed in all wrist orientations (straight, pitch, yaw).A blue reload was installed and fired on a silicone test sheet.Firing completed successfully, with a fully completed cut and proper staple formation.The reported complaint could not be replicated or confirmed via the system logs.The system logs show the instrument fired 6 blue reloads in its last procedure, and all firings were completed per the system logs.Isi also received 4 blue stapler 45 reloads.Three reloads were found to be unfired.No trouble was found with an inspection of the three reloads.The fourth reload was found to have leadscrew damage starting at roughly 35% completion and ending at roughly 80% completion.Leadscrew damage is created when the shuttle meets resistance during firing.The shuttle traveled all the way to the end position, but the knife was found rotated backwards near the distal end of the reload.Since there was no firing failure error code in the system logs, this suggests the shuttle may have broken.Disassembly of the reload confirmed a broken shuttle fragment, which is likely caused by firing across an obstruction.The shuttle retention feature for the rear knife lug broke off at its base.The knife also exhibited indentations near the bottom of the cutting edge which is indicative of firing across an obstruction.The user manual warns against firing across obstructions due to possible incomplete cutting action and/or improperly formed staples.In addition, the video provided by the site was further reviewed by an isi clinical development engineer (cde).The video reveals that the stapler 45 instrument clamped successfully.There were no holes or tears in the tissue prior to the instrument clamping and firing.The jaws of the instrument were positioned across three sets of previously placed staple lines.While firing a reload, no errors or faults were detected.Upon releasing the tissue from the instrument's jaws, a hole is identified around the middle of the blade's intended cut line.Tissue is not cut proximal or distal to the hole.No error or faults were detected during the cut function of the stapler 45 instrument.After the cut function is performed, a staple from a previously placed staple line appears to be caught in the blade track which causes some difficulty in freeing tissue from the instrument's jaws.The stapler 45 instrument is eventually removed without further clamping or firing.The intended cutting line is eventually finished via cold cutting and monopolar energy using a monopolar curved scissors (mcs) instrument.The stapler instrument is not further re-installed or further used in the video provided.Based on the current information provided at this time, this complaint will remain reportable due to the following conclusion: during the da vinci-assisted surgical procedure, the stapler 45 instrument allegedly had an incomplete cut incident.As a result, the surgeon completed the staple line transection with a mcs instrument and oversewed the staple lines with sutures as a precaution.There is no indication that a malfunction of the stapler 45 instrument or reload occurred based on failure analysis investigations.

• Brand Name: ENDOWRIST; DAVINCI SI
• Type of Device: STAPLER 45
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 950 kifer rd.; sunnyvale
• MDR Report Key: 7557064
• MDR Text Key: 109664916
• Report Number: 2955842-2018-10242
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111093
• UDI-Public: (01)00886874111093(10)T10171114
• Combination Product (y/n): N
• PMA/PMN Number: K113706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410298-11
• Device Lot Number: T10171114 98
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Date Manufacturer Received: 05/30/2018
• 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