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); Wound Dehiscence (1154); Abscess (1690); Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 10/11/2023.D4: batch # unk.B3: exact event date unk, entered 1/1/2023 as only the year was provided.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.

Event Description

Title: three- versus two-rows circular staplers for left-sided colorectal anastomosis: a propensity score-matched analysis of the icral 2 and 3 prospective cohorts.Citation: international journal of surgery publish ahead of print; doi:10.1097/js9.0000000000000480.The aim of the present study was to evaluate the effectiveness of the 3-rows circular stapler in reducing the risk of early adverse events in a population of patients who underwent left colectomy and/or anterior resection with end-to-end stapled colorectal anastomosis, compared to a control population in which a 2-rows circular stapler was used.A total of 2,799 patients who underwent colorectal resection with anastomosis (laparoscopic, robotic, open or converted approach, including planned hartmann¿s reversals) from january 2019 to june 2020 in 38 surgical centers (icral2), and from october 2020 to september 2021 in 76 surgical centers (icral3) were included in the study.There were 1363 males and 1436 females with 1,399 aged less than 65.2 years and 1,400 aged 65.2 years and above.The patients were divided into 2 groups, the treatment group and the control group.For the treatment group, 488 patients underwent the procedure with 3-rows circular stapler using a competitor¿s devices (manufacturer: covidien).For the control group, 2311 patients underwent the procedure with 2-rows circular stapler using devices from several manufacturers which included echelon powered staplers (ethicon endo-surgery) in 172 patients, ethicon curved intraluminal stapler (ethicon endo-surgery) in 764 patients, endoscopic curved intraluminal stapler (ethicon endo-surgery) in 122 patients and competitors¿ devices (manufacturers: covidien, touchstone, and others) for the rest of the patients.In conclusion, this study clearly highlighted that technological change in stapling devices may play a definite role in limiting the risk of anastomotic leakage and its related morbidity.

• 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: 17912694
• MDR Text Key: 325396507
• Report Number: 3005075853-2023-07386
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/11/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ILSX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/11/2023
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other