MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE INJECTOR; INJECTOR AND SHEATHSET

Model Number NM-400U-0525

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2016

Event Type  Injury  

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 a polypectomy, the two subject devices were used.It was informed that the doctor additionally applied anesthesia to the patient since the drug solution could not be inject to the tissue with the use of the subject devices.The intended procedure was completed with another device.No patient injury was reported.This is the second of two reports.

Manufacturer Narrative

This is a supplemental report for mfr report # 8010047-2016-10045 to provide additional information based on the evaluation of the device.The subject device was returned to olympus medical systems corp (omsc) for evaluation.The subject device was un-used.As the result of checking the manufacturing record of the subject device, there was nothing abnormal found.Based on the additional information, it was found that two subject devices were not used, but omsc received two subject devices.The subject device was not used.Therefore, we are retracting mdr.Cross reference mfr.Report number: 8010047-2016-10046.

• Brand Name: SINGLE USE INJECTOR
• Type of Device: INJECTOR AND SHEATHSET
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 8142642517
• MDR Report Key: 6088676
• MDR Text Key: 59451740
• Report Number: 8010047-2016-10045
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: NM-400U-0525
• Device Lot Number: K6203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2016
• 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
• Patient Outcome(s): Other