MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. OLYMPUS ESG-100, 100...120 V~,; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number WB991046

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

Patient Problems Hemorrhage/Bleeding (1888); Bowel Perforation (2668)

Event Date 06/13/2022

Event Type  Injury  

Manufacturer Narrative

The literature described model number "esg-100, esg-300", and olympus selected "esg-100 (wb991046)" as a representative product.This event involves six related patient identifiers: (b)(6).This medwatch is for patient identifier (b)(6).The literature article is attached and doi: 10.1002/aid2.13344 is provided for additional information.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Event Description

Olympus reviewed the literature titled "risk factors for perforation during colorectal endoscopic submucosal dissection." endoscopic submucosal dissection (esd) achieves higher en bloc resection rates than endoscopic mucosal resection in early colorectal neoplasms.However, perforation occurs more frequently during esd.We aimed to identify the risk factors for perforation during colorectal esd.A total of 161 patients treated with colorectal esd at a tertiary center between (b)(6) 2014 and (b)(6) 2019 were enrolled in this retrospective study.Perforation was defined as a deep defect of the muscularis propria, with or without direct contact with connective tissue outside the colon.Clinical risk factors for perforation during esd, including age, sex, tumor morphology, tumor size, tumor location, procedure time, en bloc resection rate, histology, and submucosal fibrosis, were analyzed.The mean size of the esd specimens was 38.2 ± 24.6 mm.The overall en bloc resection rate was 98.1%.Perforations occurred during esd in 31 out of 161 patients (19.3%).All perforations were successfully treated with endoscopic closure using the hemoclips and nonsurgical management.Emergency surgery was not required in our patients.On multivariate analysis, severe submucosal fibrosis (odds ratio [or] 3.06; 95% confidence interval [ci] 1.23-7.59; p =.016) and location in the right colon (or 4.54; 95% ci 1.31-15.79; p =.017) were independent risk factors.Perforation during colorectal esd occurred in 31 patients (19.3%), but all patients had a good outcome without surgery.Submucosal fibrosis and its location are risk factors for perforation during esd.Type of adverse events/number of patients: perforation - 31 patients minor bleeding - number of patients not specified.All perforations that occurred during colorectal esd were successfully managed with endoscopic closure without rescue surgery.Most cases showed minor bleeding, which were successfully managed with immediate hemostasis by hemoclipping and coagulation.

• Brand Name: OLYMPUS ESG-100, 100...120 V~,
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18685061
• MDR Text Key: 335293866
• Report Number: 3002808148-2024-01282
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WB991046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DISPOSABLE DISTAL ATTACHMENT (D-201-15004); EVIS LUCERA ELITE COLONOVIDEOSCOPE (PCF-H290ZI); EVIS LUSERA COLONOVIDEOSCOPE (PCF-Q260AZI); SINGLE USE ELECTROSURGICAL KNIFE (KD-655); SINGLE USE INJECTOR (NM-610U-0423)
• Patient Outcome(s): Required Intervention