MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-650

Model Number KD-650Q

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause could not be conclusively determined.A supplemental report will be submitted, if additional and significant information becomes available at a later time.

Event Description

During an unspecified therapeutic, the distal knife of the subject device was fallen off into the patient.It was not reported whether the fragment was retrieved or not.No patient injury was reported.No further information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the subject device.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.There were no defects affected to falling off.As the result of checking the manufacturing record of the same lot, there was nothing abnormal detected.Based on the evaluation of the subject device, there was no malfunction which caused or might cause the fragment to fall inside the patient.Therefore, we are retracting mdr.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-650
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 8142642517
• MDR Report Key: 6506561
• MDR Text Key: 73232854
• Report Number: 8010047-2017-00472
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK092309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-650Q
• Device Lot Number: K6908
• Other Device ID Number: 04953170265778
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1