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

Model Number KD-650Q

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

Patient Problem Bowel Perforation (2668)

Event Type  Injury  

Event Description

It is reported in the literature article titled "esd with double-balloon endoluminal intervention platform versus standard esd for management of colon polyps" appearing in the aug 2020 issue of endoscopy international, following a colonoscopy with double balloon endoluminal intervention using a pentax single-channel video endoscope, an olympus disposable distal cap, and an olympus single use electrosurgical knife, one patient experienced a bowel perforation.No information was provided regarding any treatment required as a result of this occurrence.There was no report of any olympus device malfunction.

• 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: 11078069
• MDR Text Key: 223798608
• Report Number: 2951238-2020-00529
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170265778
• UDI-Public: 04953170265778
• 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: 11/29/2020,12/28/2020

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 Model Number: KD-650Q
• 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: 11/29/2020
• Date Report to Manufacturer: 11/29/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other