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

Model Number TJF-160VR

Device Problems Contamination (1120); Material Twisted/Bent (2981); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Manufacturer Narrative

The device is returned and an evaluation completed for it.Upon inspection of the device, it was observed that the forceps elevator has foreign material and that the forceps elevator wire (k-wire) is cut with a bent part.The forceps control lever was also dirty.The presence of dirt and foreign material is attributed to insufficient cleaning.Due to the foreign material there is clogging in the forceps elevator channel and water cannot be supplied.Other observations for the device are: objective lens, grip, switch (sw) 1, cover, universal cord, and channel tube have a scratch; distal end rubber coating (a-rubber) adhesive is detached; connecting tube has a wrinkle; universal cord has a dent; forceps channel port is shaved; angulation is low; due to fray of k-wire, forceps raising angle does not meet the standard value; and light guide lens has discoloration.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

The customer sent this device for inspection with no reported malfunction.There is no reported harm to any patient.Upon evaluation of the returned device, it was observed that the forceps elevator has foreign material and that the forceps elevator wire (k-wire) is cut with a bent part.The forceps control lever was also dirty.The presence of dirt and foreign material is attributed to insufficient cleaning.This medwatch is being submitted for the reportable issues of foreign material in forceps elevator, dirty forceps control lever, and k-wire having a bent part, as observed during device evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct e2/e3.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 could not be determined.Event 1: foreign material was found adhered to the forceps elevator.It was confirmed that foreign material was adhered to the forceps elevator, however, the specific material could not be identified.It is likely the event was caused by lack of reprocessing by the user.The customer reported they could not complete reprocessing as they found a cut on the forceps elevator wire (k-wire).There were no reported deviations from the instructions for use (ifu).Event 2: the forceps control lever was dirty.It is likely the user could not complete reprocessing due to the cut k-wire, which led to this event.Event 3: k-wire strands were cut/frayed (strands raised).It is likely strands from the k-wire became cut due to fatigue breakdown from repeated manipulation of the forceps elevator, which then resulted in a raised k-wire due to repeated brushing around the forceps elevator and attachment/detachment of the distal cover.The event can be detected and prevented by following the instructions for use (ifu) which state: "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

Additional information has been received for this event.This supplemental report is being submitted to provide this information.Customer does not known when the forceps elevator wire (k-wire) was bent.Reprocessing steps for the forceps elevator and the rest of the device were not performed for this device in this case; however, information on general reprocessing at the facility is provided.In general, the customer follows all the necessary steps as per instructions for use (ifu) recommendations and possess all the required brushes to clean the device.General information of reprocessing at the facility: an air water channel cleaning adapter is used for pre-cleaning, which is performed immediately after a procedure.Detergent used for pre-cleaning is gigazyme.The endoscope channels are brushed during manual cleaning with an olympus reusable bw-20t brush.If a single use brush is used, it is not reused.Cleaning and disinfectant solutions used with the endoscope are cidex-opa solution.The forceps elevator is brushed with mh-507.The forceps elevator is operated in the detergent solution.The forceps elevator is flushed appropriately.The distal end is brushed with the channel-opening brush and with maj-1534.Automatic endoscopy reprocessor (aer) used is not olympus brand but endo wash by vsm health tech customer is not using olympus aer but endo wash by vsm healthtech.No information provided on the detergent and disinfectant used with the aer.There are no issues with the aer.The endoscopes are dried in a endoscope cabinet and stored in almirah cabinet for endoscopes.

Event Description

Addendum jan 31, 2023: customer sent the device for repair without any reprocessing as there was a cut found in the forceps elevator wire (k-wire).There is no procedure involved nor any patient involvement in the event.

• 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: 15564201
• MDR Text Key: 306594924
• Report Number: 9610595-2022-02720
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• 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: 09/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2007
• 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