MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA DUODENOVIDEOSCOPE

Model Number TJF-160VR

Device Problems Crack (1135); Device Contamination with Chemical or Other Material (2944); Material Split, Cut or Torn (4008)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation.The pipe from the forceps raiser system was deformed.Debris was found inside the light guide lens.A chip was found the light guide lens.Cracks were found on the light guide lens and the cover lens.The cracked cover lens caused the subject device to fail the leak test.Scratches were found on the connecting tube, button (keytop) one (1) on the switch and universal cord.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, there was a forceps/instrument channel malfunction on the exis exera duodenovideoscope during reprocessing.During inspection of the returned device, a pipe was torn and there was a crack in the light guide adhesive area and debris inside the light guide lens.There were no reports of patient harm associated with this event.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

This supplemental report is submitted to provide the results of the legal manufacturer¿s investigation and the device history record (dhr) review.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The investigation determined the most likely cause of the torn and frayed wire was due to fatigue breakdown caused by the repeated operation of the forceps elevator and it became frayed by the repeated brushing and cleaning around the forceps elevator and attachment/detachment of the distal cover.The investigation determined the most likely cause of gap at the distal end glue and the inside of the light guide lens being dirty was the gap generated at the light guide lens due to physical stress and the gap then allowed the introduction of dirt to enter the lens.This caused moisture to be introduced, causing corrosion.Instructions for use (ifu) provides the users with instructions on how to detect and prevent these failures.Forceps elevator wire: ¿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.¿ users can reduce the occurrence of this failure by reprocessing the device in accordance with the following ifu: ¿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.¿ users can also reduce occurrence of the by attaching distal cover properly in accordance with the ifu.Gap at distal end glue and inside the light guide lens being dirty: users can prevent or detect abnormality of the suggested event by handling the device in accordance with the following ifu.Ifu(operation manual) ¿·do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.·inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.¿ -ifu(reprocessing manual) ¿be sure to perform a leakage test on the endoscope prior to manual cleaning.Do not use the endoscope if a leak is detected.Use of an endoscope with a leak may cause a sudden loss of the endoscopic image, damage to the bending mechanism, or other malfunctions.¿ olympus will continue to monitor the field performance of this device.

Event Description

The procedure which had occurred prior to the reprocessing was completed with the same device.

Manufacturer Narrative

This supplemental report is submitted to provide additional information obtained from the customer.

• Brand Name: EVIS EXERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13468943
• MDR Text Key: 285166628
• Report Number: 8010047-2022-02463
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2022

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: 01/16/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 02/07/2022; 02/25/2022
• Supplement Dates FDA Received: 03/09/2022; 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2007
• 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