MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-655

Model Number KD-655Q

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

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined.Since the lot number is unknown, the device history record could not be reviewed.However, omsc has only shipped devices that passed the inspection.Based on the reported event, it is presumed that the reported complication was not due to the malfunction of the device.

Event Description

On january 29, 2020, olympus medical systems corp.(omsc) received literature titled ¿dexmedetomidine for conscious sedation with colorectal endoscopic submucosal dissection: a prospective double-blind randomized controlled study¿.In the subject procedures, it was reported that postoperative bleeding occurred.The literature indicated that kd-655q was used for the dissection during the esd.Based on the available information, a direct relationship between the olympus product and the observed adverse events could not be determined.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-655
• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9726326
• MDR Text Key: 192675121
• Report Number: 8010047-2020-01448
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2020

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: No Information
• Device Model Number: KD-655Q
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• 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