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

Model Number KD-640L

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

Patient Problem Pneumothorax (2012)

Event Type  Injury  

Event Description

It is reported in the literature article titled "peroral endoscopic myotomy achieves similar clinical response but incurs lesser charges compared to robotic heller myotomy, " five patients in the peroral endoscopic myotomy (poem) group experienced an adverse event. This was a retrospective single center review of 52 consecutive poem procedures between 2012-2014, and 52 consecutive rhm procedures between 2009-2014 with the primary aim of comparing the inpatient charges incurred by patients undergoing poem or robotic heller myotomy (rhm) for the treatment of achalasia. In all poem cases, an olympus kd-640l was used. There is no report of device malfunction during any of these procedures. Five patients in the peroral endoscopic myotomy (poem) group experiencing an adverse event (pneumothorax (1), mucostomies (4). No information was provided regarding any treatment required for these reported events. This report is being submitted to report the potential that an olympus device could have caused or contributed to a reported adverse event.

• 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: 11587850
• MDR Text Key: 242897841
• Report Number: 2951238-2021-00306
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/07/2021,03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: KD-640L
• 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: 03/07/2021
• Event Location: No Information
• Date Report to Manufacturer: 03/07/2021
• Date Manufacturer Received: 03/29/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 03/30/2021 Patient Sequence Number: 1