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

Model Number TJF-Q180V

Device Problem Mechanical Jam (2983)

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

Event Date 02/02/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user report was confirmed, the switch was damaged and causing the device to not capture images.Additionally, the distal end adhesive was cracked.The light guide lens had tiny chips present.The control knob was in the 'play' position, and the forceps elevator k-pipe holder needed replacing.If additional information becomes available following the device evaluation, a supplemental report will be filed.

Event Description

The customer originally returned his olympus evis exera ii duodenovideoscope due to the unit being unable to take pictures while reprocessing.This event had no patient involvement.During the device evaluation, it was discovered that the forceps raiser was caught.This report is being submitted to capture the caught forceps raiser noted during the evaluation.

Manufacturer Narrative

This supplemental report is being submitted to correct the aware date of the initial mdr from feb 7, 2022, to feb 3, 2022, and to provide additional information based on the legal manufacturer¿s investigation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.The root cause of the issue could not be conclusively specified.However, the legal manufacturer stated, based on the evaluation results, they presumed that the forceps elevator breakage was caused by external stress such as striking or dropping of the distal end of the subject device.The light guide lens cracked can also be attributed to external stress applied to the distal end.The distal end cover and l-arm were replaced likely due to the broken forceps elevator.The instructions for use states that endoscope may be damaged by being dropped or struck.The user can properly detect the suggested event by handling device in accordance with the following ifu statement: ¿inspection of the forceps elevator mechanism 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 user can prevent / reduce the suggested event by handling device in accordance with the following ifu statement: ¿important information ¿ please read before use.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.¿ a review of the complaint database did not find any similar event from the same facility and/or with the same device.However, there is one similar complaint found from a different user facility.

• Brand Name: EVIS EXERA II 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: 13664124
• MDR Text Key: 296765672
• Report Number: 8010047-2022-03916
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170339967
• UDI-Public: 04953170339967
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2022

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-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2014
• 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