MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP.

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

The subject device will not be returned to olympus medical system corp.(omsc) for investigation.Omsc has not finished the investigation yet.The exact cause could not be conclusively determined at this time.This report will be supplemented as soon as the investigation is completed.

Event Description

It was reported that there were bleedings of four cases after colorectal endoscopic submucosal dissections.Olympus electrosurgical knife was used during each procedure.After the procedure, bleeding occurred.The user performed the hemostasis treatment.There was no patient injury reported except the event.No further information was reported.Based on the reported information, there is a possibility that either kd-650 or kd-612 was used.This mdr is about the fourth of the four cases reported.

Manufacturer Narrative

The subject device was not returned to olympus medical system corp.(omsc).Therefore, omsc could not evaluate the reported device.The exact cause of this issue could not be conclusively determined.Since the lot no.Is unknown, the manufacturing history record could not be reviewed.However, omsc has only shipped devices which passed the inspection.From the reported information, it is assumed that the event did not occur due to malfunction of the device, but occurred as a general accidental symptom of the procedure.

• 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 ; 426425177
• MDR Report Key: 7008672
• MDR Text Key: 91292706
• Report Number: 8010047-2017-01689
• 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,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2017
• 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