MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE INJECTOR; INJECTOR AND SHEATHSET

Model Number NM-401L-0423

Device Problems Mechanical Problem (1384); Failure to Deliver (2338); No Flow (2991)

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

Event Date 12/12/2022

Event Type  malfunction  

Manufacturer Narrative

In communication with the customer it was conveyed that it has been a while since the incident, but they seem to remember that they tested the needle (that the needle went back and forth) before putting it through the scope.Nurses who were present do not remember.It was understood according to the reporter, that it is routine for the nurses to test whether the needle can be passed back and forth in the catheter, but there is uncertainty as to whether they test it to see if fluid can be passed through when the needle is advanced and ready for injection.There was no patient injury, but the treatment could not be carried out as planned.The patient was set up for a check-up after a month and they were then able to carry out the treatment as planned.Customer did not take care of the needle, it was thrown away.Legal manufacturer investigation: the subject device was not returned to olympus for the following reasons: ·the customer discarded the subject device.The subject device was not returned to olympus.Therefore, the reported phenomenon and condition of the device could not be confirmed.The lot was not provided and the manufacture date could not be identified since the subject device was not returned.The device history record (dhr) with the subject lot number was confirmed for the lots 1xv14 through 2xv13* since the lot number of the device was not provided.No abnormalities were detected in the dhr for the following items, which related to the reported phenomenon.*these lots were manufactured one year before the event date.¿ process inspection sheet ¿ quality inspection sheet ¿ nonconforming product report instruction for use (ifu): the instruction manual contains the following descriptions, and it warns against this event.(rk1556 rev.02) ¿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.¿do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.¿before use, confirm that the needle and the insertion portion are not damaged.If any abnormalities such as significant deformations or excessive bends are found, do not use the instrument.Otherwise, it may cause perforation, bleeding, mucous membrane damage.¿confirm that the needle extends in the endoscopic image are normal.If any abnormalities are found, do not use the instrument.Otherwise, it may cause perforation, bleeding or mucous membrane damage.¿when inserting the instrument into the endoscope, retract the needle into the tube, 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.¿do not push the slider abruptly; otherwise, the needle will be rapidly extended from the distal end of the tube.This could result in patient injury, such as perforation, bleeding or mucous membrane damage.It could also damage the instrument.From a similar complaint in the past, it was likely that the phenomenon ¿unable to inject liquid into the target tissue¿ occurred due to the compressive bucking on the needle tube.It is unlikely a unit with defective needle is shipped as device 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.

Event Description

It was reported, in connection with a procedure where the esophagus was to be blocked, steroids were to be injected as an additional treatment.When the needle was in, the user could not get the bag through and therefore did not get an injection.Another needle was tried (a new needle) , however, the same problem recurred.There was no patient harm, no user injury reported due to the event.This event is related to a report with patient identifier (b)(6) (1st needle ) this report is being submitted to capture the second needle failed during the event reported as confirmed by the customer during a follow up.

• Brand Name: SINGLE USE INJECTOR
• Type of Device: INJECTOR AND SHEATHSET
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16616445
• MDR Text Key: 312247087
• Report Number: 9614641-2023-00426
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 04953170422621
• UDI-Public: 04953170422621
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K902736
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2023
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: STEROIDSCOPECATHETER