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); Peritonitis (2252); Post Operative Wound Infection (2446)

Event Date 07/20/2020

Event Type  Death  

Manufacturer Narrative

(b)(4).Batch # unknown.(b)(4).Product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.Additional information was requested, and the following was received: could you please provide more details how each issue was addressed for the following events (occur intra-operatively or post-operatively, treatment, medical or surgical interventions performed: n=1 in-hospital death due to pan peritonitis after anastomotic leakage n=13 ileus n= 13 wound infection n=17 anastomotic leakage n=10 bleeding complications does the surgeon believe that was a result of either of the ethicon devices? response received: no further information will be provided because we can¿t get any additional information from the author.Information is obtained that was not available for the initial report, a follow-up report will be field as appropriate.

Event Description

It was reported via journal article: title: comparison of the continuation and discontinuation of perioperative antiplatelet therapy in laparoscopic surgery for colorectal cancer: a retrospective, multicenter, observational study (ycog 1603) author/s: hiroki ohya, jun watanabe, yusuke suwa, kazuya nakagawa, hirokazu suwa, mayumi ozawa, atsushi ishibe, chikara kunisaki, itaru endo citation: doi: 10.1002/ags3.12387.This study aimed to examine the effect of continuing antiplatelet therapy in the perioperative period for patients undergoing laparoscopic resection for colorectal cancer who had received preoperative antiplatelet therapy.A total of 214 colorectal cancer patients who received antiplatelet therapy preoperatively and underwent laparoscopic surgery for colorectal cancer between january 2011 and may 2020 were included.The study population was limited to patients who used antiplatelet therapy preoperatively.Eighty-nine patients underwent surgery under the continuation of antiplatelet therapy, and 125 patients underwent surgery under the discontinuation of antiplatelet therapy before surgery.Laparoscopic surgery for colorectal cancer (crc) was usually performed with five ports.Lymph node dissection and colon or rectum mobilization, including central vascular ligation of the artery and vein, were all performed laparoscopically.Sigmoidectomy and rectal resection with anastomosis using the double stapling technique (dst) were performed with two 12-mm ports and three 5-mm ports, and statistical analyses colectomy with antiperistaltic side-to-side anastomosis functional end-to-end anastomosis (feea) was performed with one 12-mm port and four 5-mm ports.Dst reconstruction was performed intracorporeally using an ils¿ (ethicon endo-surgery) circular stapler.Feea reconstruction was performed extracorporeally using an echelon flex¿ (ethicon endo-surgery), a signia, or an i-drive (medtronic) stapler.There were no significant differences between the two groups with regard to intraoperative blood loss (p =.889), intraoperative blood transfusion (p = 1.000), and conversion to laparotomy (p = 1.000).There were no significant differences between the two groups in the incidence of postoperative hemorrhagic complications (clavien-dindo grade =ii, p =.453; grade =iii, p =.572).There was one in-hospital death in each group.Regarding the details of in-hospital death, the in-hospital death in the c-apt group was due to pan peritonitis after anastomotic leakage, while that in the d-apt group occurred due to rupture of a thoracic aortic aneurysm.Reported postoperative complication included in-hospital death due to pan peritonitis after anastomotic leakage (n=1), ileus (n=13), wound infection (n=13), anastomotic leakage (n=17) and bleeding complications (n=10).In conclusion, present study revealed that there were no significant differences in the surgical outcomes and postoperative complications between colorectal cancer patients who underwent laparoscopic resection with the continuation of antiplatelet therapy in the perioperative period and those in whom antiplatelet therapy was discontinued during the perioperative period.From the viewpoint of cardiovascular and cerebrovascular risk, it may be better for patients undergoing laparoscopic surgery for colorectal cancer to continue antiplatelet therapy.

• 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: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 12273498
• MDR Text Key: 264927623
• Report Number: 3005075853-2021-04426
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2021

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 Catalogue Number: ILSX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/05/2021
• Initial Date FDA Received: 08/04/2021
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention