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

Model Number NM-401L-0423

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The exact cause has been under investigation.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed by the health professional that during using four devices, the following event occurred.The following event occurred on the three devices: the device was unable to inject the liquid.When the needle protruded from the sheath, the syringe could not be moved hard (heavy).The device was able to inject liquid when the needle retracted into the sheath.The intended procedure was completed with the fourth device.There was no patient injury reported.This is the third one of three reports.

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 extend from the outer tube.It was not possible to inject liquid when the slider was pushed.However, it was possible to inject liquid when the slider was pulled.The tube was buckled apploximately at 310mm from the distal end and the root of the handle section.The needle tube presented compressive buckling.No other abnormalities that could lead to the phenomenon of the reported event could not be confirmed.The manufacturing record was reviewed and found no irregularities.It is determined that liquid could not be injected due to compressive buckling of the needle tube.Since friction resistance between the outer tube and needle tube has increased, compressive buckling might have occurred when the needle was extended.A likely mechanism causing friction resistance between outer tube and needle tube might be the following: the tube was coiled during the inspection for operation the slider was pushed abruptly.Kink of the tube.A bending force might have been applied to the tube when the device was inserted into the endoscope, removed from the sterile package or during pre-inspection.This might have caused the tube to buckle.Nm-401l series undergo 100% inspection for appearance, needle operation and injection during production process.Therefore, it can be inferred that handling the device at the facility might have contributed to the reported event.The above device handling has warned in the instruction manual.

• 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: 11963783
• MDR Text Key: 271310644
• Report Number: 8010047-2021-07278
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-401L-0423
• Device Lot Number: K0709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1