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

Catalog Number ILSX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Failure to Anastomose (1028); Hemorrhage/Bleeding (1888); Cardiogenic Shock (2262); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Insufficient Information (4580)

Event Date 05/20/2022

Event Type  Injury  

Event Description

It was reported via journal article: title: an innovative and convenient technique to reduce anastomotic leakage after double stapling anastomosis: laparoscopic demucositized suture the overlapping point of the ¿dog ear¿ area.Author: xiaojiang yi1 · weilin liao1 · xiaochuang feng1 · hongming li1 · zhaoyu chen1 · jiahao wang1 · xinquan lu1 · jin wan1 · jiaxin lin1 · xiaoyan hong2 · dechang diao1.Citation: updates in surgery (2022) 74:1645¿1656 https://doi.Org/10.1007/s13304-022-01282-w.This retrospective study aims to investigate an innovative and convenient technique of laparoscopic demucositized suture the overlapping point of the ¿dog ear¿ area after the double stapling anastomosis (lds-dsa), as an improved alternative for conventional double stapling anastomosis (dsa), and whether it could reduce the anastomotic leakage (al) rate in laparoscopic anterior resection (lapa-ar).From january 2018 to december 2020, 245 consecutive cases in which performed laparoscopic radical resection of sigmoid colon or rectal cancer (dixon procedure) were analyzed.They were divided into two groups: 99 cases , (72 males and 27 females) with mean age of61.42 ± 9.40 years underwent laparoscopic demucositized suture the overlapping point of the ¿dog ear¿ area after the double stapling anastomosis (dsa) technique, named as laparoscopic demucositized suture the overlapping point of the ¿dog ear¿ area after the double stapling anastomosis (lds-dsa) group; 146 cases (97 males and 49 females) with mean age of 60.79 ± 12.12 years, underwent traditional double stapling anastomosis (dsa) technique, named as double stapling anastomosis (dsa) group.During surgery, a laparoscopic linear stapler (ecr60d, echelon flex articulating endoscopic linear cutters and reloads, ethicon endo-surgery, inc.Puerto rico usa) was applied to the rectum using one cartridge and the staple line, which would form ¿dog ear¿.The intestine was cut off 10 cm from the proximal edge of the tumor, and the next step to open and purse-string suture proximal intestine by using 2¿0 polypropylene after inserting the ¿mushroom head¿ of the circular stapler (ecs, ils endoscopic curved intraluminal stapler, ethicon endo-surgery, inc.Puerto rico usa).Disposable model according to the diameter of the intestine (ecs 25a to 33a, usually 29a),were selected and then removed the surrounding intestinal fat and colon mesenteric tissue, and return the intestine to the abdominal cavity.When the anastomosis was accessible, the assistant detected whether the anastomosis is complete through the finger, and judged whether there is anastomotic bleeding by observing the blood carried by the glove at the time of withdrawal.Then the air pumping test was carried out, if the test was positive, we would perform prophylactic ileostomy.Taking a 3-0 vicryl absorbable suture (vcp311h, vicryl ¿ plus, ethicon) with a tailored length of about 15 cm, the surgeon made a laparoscopic suture on the two ¿dog ears¿ with the exposure of the assistant.A perioperative follow-up plan for 30 days after the operation was made.Reported complications included: double stapling anastomosis (dsa) group: (n=12) anastomotic leakage (grade ii: 2, grade iiib: 10).(n=3) postoperative ileus (grade ii).(n=1) cardiogenic shock (grade iv).(n=6) intraoperative transfusion.(n=42) prophylactic ileostomy , was carried out if air pumping test was positive in the anastomosis.Laparoscopic demucositized suture the overlapping point of the ¿dog ear¿ area after the double stapling anastomosis (lds-dsa) group: (n=2) anastomotic leakage (grade iiib: 2).(n=3) postoperative ileus (grade ii).(n=1) incision infection (grade iiia).(n=3) intraoperative transfusion.(n=24) prophylactic ileostomy, , was carried out if air pumping test was positive in the anastomosis.It was concluded ,that the study results showed a lower anastomotic leakage (al) rate in the laparoscopic demucositized suture the overlapping point of the ¿dog ear¿ area after the double stapling anastomosis (lds-dsa) group.In the surgery for dsa procedure, laparoscopic demucositized suture the overlapping point of the ¿dog ear¿ area should be a feasible and safe method.

Manufacturer Narrative

(b)(4).Batch # unknown.(b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the author/surgeon believe that the ethicon device, circular or the echelon stapler, caused or contributed to the patient complications mentioned in the article? if yes, please explain.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

• Type of Device: LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 15698152
• MDR Text Key: 302698636
• Report Number: 3005075853-2022-07369
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• 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
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention