MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN); LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

Catalog Number ILSX

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

Patient Problems Failure to Anastomose (1028); Abscess (1690); Fistula (1862)

Event Date 01/01/2021

Event Type  Injury  

Event Description

It was reported that a patient with recently diagnosed adenocarcinoma underwent a robotic low anterior resection, total mesorectal excision, abdominal lymphadenectomy, and high ligation of major mesenteric vascular pedicle surgery.The op report indicates patient was ¿noted to have a very fatty rectal and colonic mesentery, and a very narrow pelvis, making this dissection exceedingly difficult.¿ the operative note further states the tumor was located several centimeters below the proximal tattoo and was ¿entirely below the anterior peritoneal reflection.¿ the rectosigmoid colon was extracorporealized and a purse string device was used around descending colon and ¿the anvil from a 29 mm eea stapler¿ was placed into the descending colon.Operative note further states a ¿28mm sizer was easily accommodated to the staple line¿ and the stapler was fired and no difficulties noted.Flexible sigmoidoscopy was performed which revealed an intact, complete, and hemostatic anastomosis with no air bubbles seen.The patient developed fluid collection on post op day two and subsequently developed abscess requiring drain placement.Over the next several months, patient developed a fistula and underwent a robotic ultra-low anterior resection and lysis of extensive intra-abdominal adhesions, takedown of rectocutaneous fistula, anastomotic revision, and diverting loop ileostomy.The surgeon decided to leave a drain in place and divert the patient proximally.The ileostomy was taken down the following year; however, patient developed anastomotic leak requiring an exploratory laparotomy, small bowel resection, and creation of ileostomy.

Manufacturer Narrative

(b)(4).Batch # unk.Date of event unknown.The lot/batch was not provided; therefore, the manufacturing records evaluation could not be performed.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

(b)(4).Date sent: 01/13/2022.Please see attached medical records.

Manufacturer Narrative

(b)(4).Date sent: 01/14/2022.Please see attached medical records.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; 6107428552
• MDR Report Key: 12853069
• MDR Text Key: 286448594
• Report Number: 3005075853-2021-07115
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ILSX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male