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

Model Number NM-400U-0525

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The needle tube of the subject device was not retracted.There was kinked on the sheath of the subject device.As the result of checking the manufacturing record of the same lot, there was nothing abnormal found.Based on the evaluation result and similar cases in the past, the needle tube might be unable to retract into the sheath because the sheath was kinked.The sheath might be kinked because excessive load was applied to the sheath when the subject device was inserted into the endoscope, when it was taken out from the sterile package, or when it was checked before use.The instruction manual of the device has already warned as follows; *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.*stop using the instrument if the insertion portion bends excessively during use.This could result in malfunction, such as failing to extend the needle or inject a fluid.

Event Description

When beginning of an unspecified diagnostic, the needle tube of the subject device could not be extended and retracted from the sheath of the subject device.On june 2, 2017, olympus medical systems corp.(omsc) confirmed that the needle tube of the subject device was not retracted into the sheath of the subject device.During the procedure, the subject device might be withdrawn from the endoscope while the needle tube was not retracted into the sheath.No patient injury was reported.

• 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 192-8 507; JA 192-8507
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 6666600
• MDR Text Key: 78384010
• Report Number: 8010047-2017-00776
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-400U-0525
• Device Lot Number: K6901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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