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

Model Number NM-400U-0423

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2016

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 a colonoscopy and polypectomy, the needle tube of the subject device could not be retracted into the sheath.It was unknown whether the intended procedure was completed or not.But no patient injury was reported.No further information was provided.

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The needle tube was not correctly extended and retracted.The sheath of the subject device was kinked.As the result of checking the manufacturing record of the same lot, there were nothing abnormal found.Based on the similar cases in the past, it is known that the needle tube could not be retracted into the sheath due to kink of the sheath.The kink of the sheath might be caused by the excessive load applied to the sheath when inserting the subject device into the endoscope, taking out the subject device from the sterile package, or in checking before use.The instruction manual of the subject device warns; when inserting the instrument into the endoscope, retract the needle into the sheath, hold the instrument close to the biopsy valve, and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.Before use, inspect the insertion portion and the tube for damage.

• 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: 6052926
• MDR Text Key: 58602801
• Report Number: 8010047-2016-10015
• 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,health professional,u
• 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: 10/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-400U-0423
• Device Lot Number: K5407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2015
• 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