MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. DUODENOVIDEOSCOPE

Model Number TJF-150

Device Problems Contamination (1120); Material Twisted/Bent (2981)

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

Event Date 09/02/2022

Event Type  malfunction  

Manufacturer Narrative

The device is returned and an evaluation completed for it.Upon inspection of the device, it was observed that forceps elevator has foreign material.There was wear around the light guide (lg) lens and inside of lg lens was dirty.The forceps elevator wire (k-wire) had a cut with a part bent.Other observations for the device are: due to deformation of electrical connector (el-connector), water tightness is lost; objective lens and universal cord have a scratch; connecting tube has a buckling and a scratch; due to damage on connecting tube, insulation resistance value does not meet the standard value; suction (s)-cover) has a dent; protector of universal cord on s-connector side has a cut; due to wear of angle wire, bending angle in up/down/left/right direction does not meet the standard value; and due to cut on k-wire, forceps raising angle does not meet the standard value.The user¿s complaint of k-wire was confirmed.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

Customer returned the device for evaluation and repair of forceps elevator wire (k-wire) being cut off.There is no harm reported to any patient.Upon evaluation of the returned device, it was observed that forceps elevator has foreign material.There was wear around the light guide (lg) lens and inside of lg lens was dirty.The k-wire had a cut with a part bent.This medwatch is being submitted for the reportable issues of foreign material in forceps elevator, inside of lg lens being dirty, and k-wire having a bent part, as observed during device evaluation.

Manufacturer Narrative

Additional information has been received for this event.This supplemental report is being submitted to provide this information.Please see the updates in sections: b3, b5, e1, e2, e3, g2, g3, g6, h2, and h10.Foreign material found in the device could not be identified.Customer does not follow the reprocessing steps per the instructions for use (ifu).Specifically, customer does not perform adequate manual brushing for distal end area and does not use detergent regularly.Customer does not use an automatic endoscopy reprocessor but reprocesses devices manually using local ga (glutaraldehyde).The start of pre-cleaning was delayed after the procedure.At the time of event, there is also may have been the possibility of presence of new and untrained staff.Customer did not perform any reprocessing at the time of return.The possibility of usage of device with foreign material cannot be denied.

Event Description

Addendum feb 9, 2023: the customer reported event of forceps elevator wire (k-wire) being cut off occurred during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure.There was a delay in the procedure of approximately 30 minutes, but the procedure was completed using another similar olympus device.Possibly, patient was administered minor additional anesthesia.There is no harm or adverse impact to the patient.The device was not inspected prior to the procedure.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the reported issues could not be determined.Although the procedure was delayed by 30 minutes, a relationship between the delay and the subject device could not be identified.Although it was confirmed that foreign material had adhered to/around the forceps elevator, the specific foreign material could not be identified.Based on the obtained information, it is likely that the reprocessing steps recommended in the instructions for use (ifu) were not performed completely due to the nonconformity of the device which caused remained foreign material at/around forceps elevator.Also, it is likely that the knob wire/forceps elevator wire (k-wire) was broken, etc., due to continuing physical stress from repeated manipulation of the k-wire and chemical stress.Finally, it is likely that the light guide (lg) lens glue was worn out and peeled off due to physical stress by hitting/dropping at the distal end of the device, etc.And/or chemical stress by chemical solutions, etc.Then, humidity invaded the lg lens which led to corrosion.The event can be detected/prevented by following the ifu which state: ¿reprocessing manual states if cleaning, disinfect, and sterilization of endoscope was insufficient, the device may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope.¿ ¿all channels of the endoscope, including the elevator wire channel where fitted, must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection-control risk to the patient and/or operators performing the next procedure with the endoscope.¿ ¿operation manual: inspection of the forceps elevator mechanism perform the following inspections while the bending section is straight.¿ ¿inspection for smooth operation 1.While observing the forceps elevator at the distal end of the endoscope, slowly move the elevator control lever all the way in the ¿u¿ direction.Confirm that the lever can be operated smoothly and that the forceps elevator is raised smoothly.Hold the elevator control lever and confirm that the forceps elevator remains stationary while pushed from behind.Visually confirm that the portion of the elevator wire extending from the distal end of the endoscope is not broken, frayed, or bent (see figure 3.5).If any damage (broken, frayed, or bent portion) is observed on the elevator wire as shown in figure 3.5, do not use the endoscope.2.While observing the forceps elevator at the distal end of the endoscope, slowly move the elevator control lever all the way in the opposite direction of the ¿u¿ direction.Confirm that the lever can be operated smoothly and that the forceps elevator is lowered smoothly.Visually confirm that the portion of the elevator wire extending from the distal end of the endoscope is not broken, frayed, or bent (see figure 3.5).If any damage (broken, frayed, or bent portion) is observed on the elevator wire as shown in figure 3.5, do not use the endoscope.¿ olympus will continue to monitor field performance for this device.

• Brand Name: DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15529116
• MDR Text Key: 306508411
• Report Number: 9610595-2022-02502
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170229459
• UDI-Public: 04953170229459
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/23/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1