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

Model Number TJF-160VR

Device Problems Material Twisted/Bent (2981); Material Split, Cut or Torn (4008); Failure to Clean Adequately (4048)

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

Event Type  malfunction  

Event Description

Customer reported with an issue of device elevator wire cut.Fse (field service engineer) visited the site found elevator wire completely cut off, wrinkles on connecting tube and the (lg) light guide lens is chip off.There was no patient harm reported.No user injury reported.Additionally, device evaluation found the inside of lens guide was found dirty, the k-wire has a cut with a bent part and forceps elevator has foreign material.

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation found the device k-wire has a cut with a bent part.The customer reported issue was confirmed.Furthermore, evaluation found inside of lg(light guide) lens is dirty and the forceps elevator has foreign material.Additionally, device evaluation findings, the following were noted.Due to wear of angle wire, bending angle in up (up/down) direction does not meet the standard value.Due to wear of angle wire, the play of knobs is out of the standard value.Due to a cut on k-wire, forceps does not rise up at all.Due to cut on k-wire, forceps raising angle does not meet the standard value.Lg-cover glass is dirty.Nozzle is deformed.Objective lens has a scratch.Adhesive on a-rubber is detached.Connecting tube has coating peeling.Connecting tube has a scratch.Connecting tube has a wrinkle.Forceps channel port shaved.S-cover has a scratch s-cover has discoloration.S-cylinder shaved.(switches)sw1& sw33 have scratches, universal cord has a scratch, s-connector has a dent.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, as well as corrections to e1, e2, g2, g3.Please see updates to b5, e1, e2, g2, h6 and h10.- the information included in e1, e2, g2 was inadvertently left out of the initial medwatch.- correction to g3 of the initial medwatch.The aware date should be 04-13-2022.Additional information was received from the customer which confirmed that the customer followed the reprocessing steps, per the instructions for use training provided to them.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the foreign material on the forceps elevator was unable to be identified.The following is included in the instructions for use (ifu): ¿ifu (reprocessing manual) states possibility that insufficient cleaning, disinfection or sterilization of device may pose an infection-control risk to the patients and operators who perform the following procedures using device.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.¿ additionally, it¿s likely the light guide (lg) lens was dirty as moisture entered the lg-lens and corroded because the lg-lens glue peeled off due to physical stress such as hitting/dropping the distal end or chemical stress due to chemical solutions used.A final root cause of the dirty lg-lens was unable to be identified.Based off the investigation results, it's likely the forceps elevator wire (k-wire) broke due to fatigue breakdown by repeated operation of forceps elevator.Moreover, the k-wire frayed and was raised by repeated brushing around forceps elevator and attachment/detachment of distal cover.However, the root cause of the event was not identified.The event (forceps elevator wire broken) can be prevented and detected by following the instructions for use which state: ¿-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.¿ the event (forceps elevator wire broken) can be prevented by following the instructions for use which state: ¿-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.

Event Description

Additional information was received from the customer and confirmed the device which had foreign material on it was not used on a patient.There was no patient harm or consequence reported as a result of the event.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 9610595.

• 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 (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14403325
• MDR Text Key: 300165105
• Report Number: 8010047-2022-08264
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2024

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: TJF-160VR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2022
• Initial Date FDA Received: 05/14/2022
• Supplement Dates Manufacturer Received: 11/25/2022; 05/09/2024
• Supplement Dates FDA Received: 01/09/2023; 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2014
• 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