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

Model Number PCF-H180AL

Device Problems Partial Blockage (1065); Failure to Clean Adequately (4048)

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

Event Date 07/12/2023

Event Type  malfunction  

Event Description

The customer reported to olympus medical that the evis exera ii colonovideoscope had channel defects.This issue was identified during customer reprocessing.The device was returned to olympus medical for evaluation.During evaluation, a cleaning brush could not be passed through the suction channel.Additional inspection identified foreign material in the channel.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.No adverse effects to patient reported.

Manufacturer Narrative

During evaluation, the following issues were identified: the distal end cover, bending section cover adhesive, switches, insertion tube, and light guide tube were scratched.The product labels were were scratched and worn.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

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.Based on the results of the investigation, the root cause could not be determined.It was confirmed that foreign material clogged the channel, however, the specific material could not be identified and the cause of the material remaining in the device could not be specified.There was no damage to the area where the foreign material was detected and it is unknown if reprocessing was performed according to the instructions for use (ifu).Three attempts were performed to obtain additional information, but no response was received from the customer.The event can be detected by handling the device in accordance with the following ifu: "-be sure to thoroughly brush the inside of the instrument channel, the instrument channel port, the suction channel, and the suction cylinder of the endoscope." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA II 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: 17510826
• MDR Text Key: 321076373
• Report Number: 9610595-2023-11551
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170339905
• UDI-Public: 04953170339905
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100584
• 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: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H180AL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2008
• 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