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

Model Number CF-EZ1500DI

Device Problem Material Too Rigid or Stiff (1544)

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

Event Date 06/23/2022

Event Type  malfunction  

Event Description

A user facility reported to olympus, the colonovideoscope was unable to angulate.Upon inspection and testing of the customer returned device, the scope angulation locked and could no disengage.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.There was no report of patient harm or user injury associated with this event.

Manufacturer Narrative

The customer suspected device was returned for investigation.The olympus service center confirmed the reported event during inspection and testing.Upon evaluation of the returned device the following defects were found, bending section rubber glue worn out, connecting tube capacitance out of range, no angulation on up and lett due to a deformation of guide plate and cp plate, biopsy channel worn, and key top n°2 damaged.The faulty parts were replaced, and the device was returned to the user facility.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

Additional information was received from the customer.The inability to angulate in the up and left directions was due to a deformed cp-plate and guide plate, which caused the coil pipes to slip out of position.The customer confirmed the angulation knob could operate without any stiffness.The customer reported the angulation wire was neither broken nor frayed, but all angle wires in the coil pipe were noticeably stretched.

Manufacturer Narrative

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

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely that the procedure was prolonged by the device¿s inability to angulate in the up and left direction.This likely contributed to the prolongation of general anesthesia.However, the root cause could not be determined.In addition, regarding the cause of no angulation on up and left, it is likely that the celling plate-stopper at up/left was detached and got under the guide plate.External stress such as hitting/dropping was likely applied to the control section while the user was handling the device.Also, the cause of the angulation on the left side did not reach the specified standards.Physical stress was likely applied to the control section during the user¿s handling, and the left side celling plate stopper got into the guide plate.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿preparation and inspection - inspection of the endoscope - inspection of the bending mechanisms - if the movement of the up/down angulation lock, right/left angulation lock, and the angulation control knobs is loose and/or not smooth, or the bending section does not angulate smoothly, the bending mechanism may have an irregularity.In this case, do not use the endoscope because it may be impossible to straighten the bending section during an examination.¿ ¿do not strike, hit, or drop the distal end, insertion tube, bending section, control section, universal cord, or endoscope connector of the endoscope.Also, do not bend, pull, or twist the distal end, insertion tube, bending section, control section universal cord, or endoscope connector of the endoscope 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.¿ this supplemental report includes a correction to event date from the initial medwatch.Olympus will continue to monitor field performance for this device.

Event Description

The following additional information regarding the event was received: the reported event occurred during a colonoscopy.There was approximately a 30-minute delay; however, the procedure was completed using another device.Although there was no change in the patient¿s condition due to this event, an increase in the duration of general anesthesia was required.

• Brand Name: 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15090172
• MDR Text Key: 304030228
• Report Number: 9610595-2022-00224
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 11/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-EZ1500DI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2021
• 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