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

Model Number TJF-160VR

Device Problems Contamination (1120); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

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

Event Date 07/28/2022

Event Type  malfunction  

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.Based on the results of the investigation, the root cause of the reported event is unable to be determined.However, the cause of the event is likely due to the reprocessing steps recommended in ifu were not performed completely due to the forceps elevator malfunctioned by the k-wire snapped, which made foreign material remain at/around the forceps elevator.The event can be detected by following the instructions for use (ifu) which state: ifu (reprocessing manual) states infection risk caused by insufficient reprocessing as follows: ¿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.¿ ifu(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.¿ ¿cleaning, disinfection and sterilization procedures - brushing around the forceps elevator and instrument channel outlet - using a stiff brush or excessive force when brushing may scratch the distal end and result in water leakage; cause the elevator wire to come off the distal end, bend or kink the elevator wire so that the forceps elevator will no longer work.¿ ¿preparation and inspection - attaching the distal cover¿.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This device is not sold in the us but a similar device is.Full name of the facility is (b)(6).The device is returned and an evaluation completed for it.The user¿s complaint was confirmed.Upon inspection of the device, it was observed that the device elevator wire was cut with parts bent and sticking out.This has likely occurred due to mechanical stress applied by user handling.There was also presence of foreign material in the forceps elevator.Other observations for the device are: due to a cut on distal end rubber coating (a-rubber), water tightness is lost; a-rubber has cut; connecting tube has a scratch and a wrinkle; insertion tube ig protector has a cut; forceps channel port is shaved; scope (s)-cover has discoloration and a dent; s-cylinder is shaved; switch (sw) 1 has a scratch; control unit has discoloration; right/left knob has discoloration; universal cord has a scratch and is deformed; s-connector has a dent; due to wear of angle wire, bending angle in up/down/right direction does not meet the standard value and play of all knobs is out of standard; adhesive around the light guide lens has a crack.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

The customer returned the device for evaluation and repair for the broken elevator wire occurring during device reprocessing.There is no harm reported to any patient.Upon evaluation of the returned device, it was observed that the device elevator wire was cut with parts bent and sticking out.There was also presence of foreign material in the forceps elevator.This medwatch is being submitted for the reportable issues of presence of foreign material in the forceps elevator and the forceps elevator wire being cut and sticking out as observed during device evaluation.

Manufacturer Narrative

Additional information has been received for this event from the customer.This supplemental report is being submitted to provide this information.It is not known how the forceps elevator coil (k-wire) was broken.Although customer followed the correct reprocessing procedure as per olympus training and instructions for use (ifu), in this case the device could not be manually brushed enough due to the k-wire being partially broken and restricting the adequate reprocessing.Therefore there is no information available for the reprocessing of the device.The automatic endoscopy reprocessor (aer) being used to reprocess endoscopes at the facility is olympus: oer-aw (serial number (b)(6).Detergent and disinfectant used with the aer are 3m (johnson and johnson).There have been no issues noted with the aer.The device is generally dried after reprocessing and stored in a closed cabinet.

• Brand Name: EVIS EXERA 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: 15266359
• MDR Text Key: 303263398
• Report Number: 9610595-2022-01169
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K024033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-160VR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2011
• 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