MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC SUREFORM; STAPLER 60

Model Number 48360B

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure to Anastomose (1028)

Event Date 02/28/2021

Event Type  Injury  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported failure mode cannot be determined or is unknown.If additional information is received, a follow-up mdr will be submitted.A site complaint history review was conducted and did not show any additional complaints related to this product.No image or video clip for the reported event was submitted for review.A system error log review was conducted for a procedure on (b)(6) 2021 on system sk1262.System messages were present but there were no observed events in the system logs that would suggest a related product issue and logged events are in line with normal system functionality.A review of the instrument logs was also performed.Single use sureform 60 stapler instrument pn: 480460-09 || ln: l90200307-0125 || sn: (b)(4) was recorded as being used in this procedure.While not all reusable instruments used in the case have been used in subsequent procedures at this time, a site history search shows no complaints filed against the instruments.An isi advanced failure analyst (afa) engineer conducted review of the stapler logs and found that the sureform 60 stapler pn 480460-09 || ln: l90200307-0125 was fired with 3 blue reloads pn 48360b.All firings were completed and there were no pauses for compression during any of the firings.Additionally, there were no incomplete clamps in the procedure.There was no report of intra-operative complications during the initial da vinci procedure.While the surgeon alleged that an anastomotic leak was related to the use of a sureform stapler instrument with blue reloads, there is no information provided that meets the criteria of a reportable malfunction.It was reported that the patient experienced complications yet, at this time, there is insufficient information provided to determine that a sureform instrument or reload malfunctioned in a way that could contribute to an adverse event if it were to recur.However, it was reported that there was a post-operative anastomotic leak that required repair in a second procedure.At this time, the root cause of the reported issue and post-operative complications is unknown.

Event Description

It was initially reported that after a da vinci-assisted right hemicolectomy procedure on friday (b)(6) 2021, there was an anastomotic leak identified a few hours post-da vinci procedure, on friday (b)(6) 2021, ¿in the middle of where the large and small bowel meets¿.The surgeon stated that the patient had ¿more than normal pain¿ post-surgery.The surgeon asked an isi representative upon the initial report if ¿the stapler 60 (pn 480460) caused the patient injury.On 01-mar-2021, intuitive surgical, inc.(isi) obtained the following additional information regarding the reported event: after a completed da vinci-assisted right hemicolectomy procedure on a (b)(6) year old female on friday (b)(6) 2021, the patient presented with symptoms of ¿more than normal pain¿ a few hours post-operatively from the da vinci procedure.The surgeon reported that on ¿post-op day 2, the patient became septic¿.A second, laparotomy, surgery was performed by a different surgeon on sunday (b)(6) 2021 where an unspecified ¿anastomotic leak¿ was identified.The follow-up surgeon allegedly said that the anastomotic leak was ¿in the middle of the staple line on the colon side where the large and small bowel meets¿ and that, ¿the cecum had twisted on itself and there was a small opening¿ and there was, ¿stool throughout the abdomen¿.The follow up surgeon resolved the issue by, ¿resecting the whole thing, cleaning it up, and re-doing the anastomosis¿.The laparotomy completed without incident and the patient was reported as doing well and recovering.According to the surgeon, the initial da vinci procedure went well with no issues.The same sureform 60 stapler instrument was used throughout the procedure on arm 3 and no system errors or messages presented.The surgeon was asked about, and the surgeon reported that, firefly icg was used to check for perfusion and that the anastomosis issue was at the point of a da vinci staple line where the sureform 60 stapler instrument had been used vs the area that the surgeon described as being handled with planned sutures.It was reported that the da initial vinci procedure completed without incident.

• Brand Name: SUREFORM
• Type of Device: STAPLER 60
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: david wang ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 11573458
• MDR Text Key: 244308035
• Report Number: 2955842-2021-10312
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/01/2021

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: 48360B
• Device Catalogue Number: 48360B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2021
• Initial Date FDA Received: 03/26/2021
• 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: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 39 YR