MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE

Model Number KD-650U

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

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Necrosis (1971); Perforation (2001); Stenosis of the esophagus (4487)

Event Type  Injury  

Event Description

It is reported in the literature article titled "endoscopic submucosal dissection (esd) in north america: a large prospective multicenter study, " out of 692 procedures/patients, 70 patient experienced adverse outcomes.This is a prospective multi-center (10) study from april 2016 through april 2020.The aim of this study was to evaluate the technical outcomes of endoscopic submucosal dissection (esd) in north america.In this study, it mentions that the most frequently used knives for this procedure include olympus dual knife (used in 476 of 692 cases) and olympus it knife (used in 214 of 692 cases).It is reported out of 692 procedures/patients, 70 patient experienced adverse outcomes.50% (35/70) classified as minor, 40% (28/70) classified as moderate and 10% classified as severe.In aggregate, delayed bleeding occurred in 2.3% (16/692) of the patients.Out of these 16 patients with delayed bleeding, 14 underwent endoscopic therapy of which three also received blood transfusions.Two out of the 16 patients with delayed bleeding were managed expectantly.Perforation was reported in 2.9% (20/692) of the cases.All cases of perforation were successfully closed endoscopically, except for one patient who presented with delayed perforation due to ischemic necrosis after esd in a lesion in the ascending colon.The patient underwent right hemicolectomy with full recovery.In aggregate, the most commonly reported adverse event was stricture formation (26/692; 3.8%).Stricture developed only after esophageal esd, and accounted for 14.4% (26/181) of the esophageal cases.Out of these, 76.9% (20/26) were symptomatic and required serial endoscopic dilations.One patient developed severe abdominal pain after colon esd for a lesion in the cecum and was diagnosed with post-polypectomy syndrome in the absence of perforation on diagnostic laparoscopy.There was no report of any olympus device malfunction in any procedure.Specific patient information is not available for each procedure.One report will be submitted to report the potential that an olympus device could have caused or contributed to an adverse event in a patient.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11574280
• MDR Text Key: 256011342
• Report Number: 2951238-2021-00303
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170265785
• UDI-Public: 04953170265785
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2021,03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: KD-650U
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/02/2021
• Date Report to Manufacturer: 03/02/2021
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention