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

Model Number PCF-H190DL

Device Problem Partial Blockage (1065)

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

Event Date 05/16/2023

Event Type  malfunction  

Event Description

A customer reported that ¿something block[ed] the channel¿ when reprocessing the evis exera elite bronchovideoscope.There were no reports of patient harm.

Manufacturer Narrative

The device was returned to an olympus repair facility and an evaluation was performed.The reported problem of blockage in the channel was confirmed.A plastic object was found in the brush passage (instrument channel).The clogged instrument channel reduced suction flow.In addition, the device was unable to pass the dunk test (leak test) caused by the blockage in the channel.The forceps (biopsy c/t) channel did not pass a test.The distal end plastic cover had a chip and a crack; the objective lens had peeling glue, chips and scratches, and the glue on the a-rubber was cracked.The right/left knob was loose, the insertion tube was scratched, and the light guide tube had surface scratches.The objective lens and air/water nozzle were replaced and sealed with sealant.The endoscope was leak and fog tested.The biopsy channel was replaced, and the distal tip and body control unit were reassembled.A new bending rubber was installed at the distal tip.The bending rubber passed suction and watertight tests.The light guide lens unit was replaced and sealed and passed a functional test.The s-cover was reseated.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h6 and h10.Three attempts were performed to obtain additional information, but no response was received from the customer.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the foreign material was a white resin.However, the foreign material was unable to be identified.Therefore, the final root cause of this event was unable to be identified.The event can be detected by following the instructions for use which state: ¿operation manual chapter 3 preparation and inspection.¿ the event can be prevented by following the instructions for use which state: ¿reprocessing manual chapter 5 reprocessing the endoscope.¿ 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: 17117549
• MDR Text Key: 317069080
• Report Number: 9610595-2023-08761
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170363672
• UDI-Public: 04953170363672
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• 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: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• 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: 05/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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