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

Model Number NM-400U-0423

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device referenced in this report was not returned to olympus for evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

During an endoscopic mucosal resection, the subject device was used.The user could not perform injection due to a large load.The intended procedure was completed with another needle.There was no patient injury reported.This is the report regarding the inability to inject into the lesion.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The needle could not inject the liquid with the needle protruded from the device.The needle could inject the liquid with the needle retracted into the device.The needle tube inside the operation part was compressive buckled.The manufacturing record was reviewed and found no irregularities.Based on the similar cases in the past, the needle might be unable to inject the liquid due to the compressive buckling on the needle tube.The compressive buckling on the needle tube was likely caused by the large friction between the outer tube and the needle tube when the needle was extended due to the following factors.1) the insertion portion was bent tightly.2) the slider was abruptly pushed.3) the insertion portion of the endoscope was tightly angulated.The above device handling has warned in the instruction manual as follows.Do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.Straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.Operate the slider slowly, otherwise the tube could buckle.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.

• 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
• MDR Report Key: 10045953
• MDR Text Key: 224679673
• Report Number: 8010047-2020-02638
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• 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: K8625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1