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

Model Number CF-H185I

Device Problem Material Too Rigid or Stiff (1544)

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

Event Type  malfunction  

Manufacturer Narrative

A company representative visited the facility and assessed the scope.The endoscope made an impression that was "as good as new." the insertion tube and the angulation part had no bruises or the like.The angulation reached full angles on all levels (180° and 160°) and also the reset after releasing the brake under 90° worked on all levels.The company representative could not detect any increased stiffness.However, the unit was stated to be more stiff than the units already at the customer's site, due to the short duration of use.The suspect device was returned to olympus and evaluated.The user reported phenomenon could not be confirmed.The device met all specifications and no problems were noted.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

A user facility reported to olympus that the evis exera iii colonovideoscope was unusually stiff.Due to this, a procedure had to be cancelled as examination with the scope was "too dangerous." additional information has been requested regarding specifics, but not received.Two reports were received related to this scope.Patient identifier (b)(6) is for a cancelled procedure.Patient identifier (b)(6) is for a splenic rupture.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.New information added to the following fields: b5.

Event Description

Additional information obtained from the head physician at the user facility stated that the device seemed normal to him (a bit stiffer because it was new), but he had worked with it without any problems.

Event Description

The customer notes the following: during the procedure, the endoscope went in through the stoma, so it couldn't have hit the spleen at all and probably previous damage to the patient as the cause of the rupture of the spleen.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.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, a specific cause of the canceled examination during procedure could not be identified.Additionally, the phenomenon of the foreign material on the light guide lens is likely due to the material is lubricant used in procedure.However, a root cause could not be determined.The event can be prevented by following the instructions for use which state: "flexibility adjustment- endoscope model: endoscopes with flexibility adjustment warning: if the rigidity of the insertion tube has to be increased during an examination, confirm that there are no loops or excessive bends in the insertion tube (if necessary, use fluoroscopy before increasing its rigidity.If the force required to turn the flexibility adjustment ring is greater during the procedure than it was when inspecting the endoscope, it may mean that the insertion tube is excessively bent inside the patient.In this case, straighten the insertion tube as much as possible before attempting to increase the rigidity.Failure to do so may cause patient pain, injury, bleeding, and/or perforation.-3.3 inspection of the endoscope- inspect the objective lens and light guide lens at the distal end of the endoscope¿s insertion section for scratches, cracks, stains, gaps around the lens, or other irregularities." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16562317
• MDR Text Key: 311737944
• Report Number: 9610595-2023-04522
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-H185I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• 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