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

Model Number NM-401L-0523

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.Therefore, the exact cause of the reported event could not be conclusively determined.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, omsc presumes that the event occurred due to the compressive bucking on the needle tube.The compressive buckling on the needle tube was likely caused when the needle was extended with increased friction resistance between the outer tube and the needle tube.The friction resistance between the outer tube and the needle increased by the following factors.The tube was coiled while the inspection of operation.The insertion part was bent tightly during use.The slider was abruptly pushed.The kink of the tube.Angle of the distal end of the endoscope.The above device handling has warned in the instruction manual as follows.Before use, prepare and inspect the instrument as instructed below.Should the any irregularity be observed, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient or user safety, for example: posing an infection-control risk, causing tissue irritation, perforation, bleeding or mucous membrane damage, and may result in more severe equipment damage. 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.Push the slider into the holder portion until it clicks into position to extend the needle from the distal end of the tube.Inject a fluid intended for patient use into the instrument¿s injection port using a sterile syringe.Confirm that the fluid comes out of the distal end of the needle.Make sure that the fluid is not discharged from any areas other than the distal end of the needle.

Event Description

During an unspecified procedure, two devices were used.The needle was blocked and the solution could not be injected on both devices.There was no patient injury reported.No further information was provided.This is the first one of two reports.

• 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: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10654332
• MDR Text Key: 223662774
• Report Number: 8010047-2020-07471
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170382352
• UDI-Public: 04953170382352
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-401L-0523
• Device Lot Number: 89K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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