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

Model Number	KD-650U
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Perforation (2001)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted to report the user's experiences and investigation findings.The devices referenced in this report were not returned to olympus for physical evaluation.The device history record (dhr) for the complaint devices could not be reviewed since the lot/serial numbers were not provided.Olympus does not ship any device that does not meet all design and safety specifications.Conclusion: no malfunction of any olympus device was reported in any procedure described in this article.From the information reported, it is presumed that the causes of the reported events are not due to product defects, but the definitive cause could not be established.
Event or Problem 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
• Common Device Name: 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: 11574105
• Report Number: 8010047-2021-04186
• Device Sequence Number: 3460495
• Product Code: KNS
• UDI-Device Identifier: 04953170265785
• UDI-Public: 04953170265785
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,literatur
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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
• Operator of Device: Health Professional
• Device Model Number: KD-650U
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention