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

Model Number CF-H190L

Device Problem Corroded (1131)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the evaluation found the following: there was a leak in the biopsy channel and bending section cover or distal sheath rubber; leak and scrapes marks were found in the forceps passage; angulation was low; control know had a play; distal end plastic cover had deep dents; bending section cover or distal sheath rubber had leak and crack on both sides; insertion tube had a buckle near bending section and excessive buckle at 15cm; light guide tube had buckles and scope connector had minor dents in the gold pin and plug unit.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus that evis exera iii colonovideoscope, command break the issue occurred an unknown event.The procedure was unknown.There were no reports of patient or user harm associated with this event.The device was returned to olympus for evaluation, and the evaluation found that light guide lens has corrosion inside.This report is being submitted to capture the reportable malfunction found during evaluation.

• 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 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18229220
• MDR Text Key: 330046246
• Report Number: 9610595-2023-18261
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170305153
• UDI-Public: 04953170305153
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K131780
• 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
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-H190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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