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

Model Number PCF-H190DL

Device Problem Mechanical Problem (1384)

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

Event Date 11/09/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, that the colonovideoscope's control knobs were stiff.The issue was found during preparation for use for a diagnostic colonoscopy.There was a 5-10 minute delay in the procedure, and it was reported that the patient was awake.The intended procedure was completed by using the same set of equipment.The device was inspected before usage.The device was returned for evaluation.During the device evaluation, the following was found: the up and down knob was engaged but could not be disengaged.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found the following: the plastic distal end cover insulation was over the threshold and was cracked, the bending section cover glue was separated, the bending tube was deformed, the metal braid and bending tube were cutting wire, the control unit and mouth guard piece for endoscopy were damaged, the universal cord's coating was peeling, the connector and plug unit had damaged housing, the angulation was less than the specified value, the angulation play failed, the distal end and air water channel was greater than the specified value, the air water nut and suction cylinder nut had paint peeling off, the charged coupled device cover lens and the light guide rod lens were chipped, and the distal end lens glue and charged coupled device cover lens glue had a pinhole.Additionally, the following had scratches: the light guide rod lens, universal cord, connecting tube, and the grip unit.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

• 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: 18246574
• MDR Text Key: 330460059
• Report Number: 9610595-2023-18516
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170363672
• UDI-Public: 04953170363672
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H190DL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2018
• 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