MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE INJECTOR; GENERAL-PURPOSE ENDOSCOPIC NEEDLE, SINGLE-USE

Model Number NM-401L-0425

Device Problem Mechanical Problem (1384)

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

Event Date 04/12/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the reported issue is unknown at this time.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Olympus representative (rep.) reported the needle with part number nm-401l-0425 was unable to inject after it had extended the needle.The issue was found during a therapeutic procedure.According to the reporter (rep.) there was no patient involved and no patient injury reported.Customer is returning the whole rest of the box of needles.There was no patient harm, no user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on device return evaluation and the legal manufacturer's final investigation.·the customer returned a new nm-401l-0425 single use injector (lot 21v 04) with supplementary information number ¿4¿ for evaluation due to "unable to inject after it had extended the needle".The user's complaint was not confirmed.·the devices were returned in the original box, which had the blue tape seal intact on both ends.A visual inspection performed and functional inspection on a sample of two of the returned devices and was unable to replicate the user's experience during testing.The injectors were received in the original package, and there were no damages, or voids to the sterile package, or seal prior to opening.The complaint device was received with the needles fully retracted.The insertion portion tube is free of residue and debris.The needle at the distal end is sharp with no dull edges.·a functional inspection was performed on both complaint devices.Functional testing attempted to extend and retract the needle out of the sheath by pushing the slider into the holder portion; the needle extended and retracted as intended.The movement during the handle manipulation was normal with no extra force required to push or pull the needle out the sheath of the injector.Further, the injection inspection was tested by filling a syringe with water and attaching it to the injection port.The water was inserted through the injector with the needle extended (push), and the fluid flowed through the tube, and out the distal end sufficiently with a normal flow.This test was also performed with the needle retracted, and the result was the same.Dhr review: the device history record for the lot found no abnormalities with the event-related items.The record review includes the following.Process inspection sheet, quality inspection sheet, and nonconforming product report.(instruction for use): the instruction manual contains the following descriptions, and it warns against this event.(gk6631 rev.11).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.Insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument.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.Conclusion summary: the exact cause could not be conclusively identified by the following reason; the user's complaint was not confirmed with returned devices.No abnormalities on the device was considered as no abnormalities were found in the device history record.From a similar complaint in the past, it was likely that the phenomenon occurred due to the compressive bucking on the needle tube.It is unlikely a unit with defective needle is shipped as nm-401l series undergo 100% inspection for appearance, needle operation and injection.Therefore the compressive buckling on the needle tube was likely caused when the needle was extended because of the great friction between the outer tube and the needle.It was likely that the friction between the outer tube and the needle increased by the following factors.The needle extended/retracted while the tube was coiled in inspection of operation.The slider was abruptly pushed.The kink of the tube.Angle of the distal end of the endoscope.Olympus will continue to monitor complaints for this device.

• Brand Name: SINGLE USE INJECTOR
• Type of Device: GENERAL-PURPOSE ENDOSCOPIC NEEDLE, SINGLE-USE
• 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: 14494209
• MDR Text Key: 292584780
• Report Number: 8010047-2022-08833
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422638
• UDI-Public: 04953170422638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NM-401L-0425
• Device Lot Number: 21V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2022
• 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