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

Model Number PCF-H180AL

Device Problems Device Reprocessing Problem (1091); Mechanical Problem (1384)

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

Event Date 03/24/2023

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.Device evaluation, forceps passage inspection was performed, found forceps and brushes unable to pass through the channel.Control body inspection noted foreign material found stuck in the forceps kc mount piece.Torn boot was observed.The reported issue was confirmed.Furthermore, the following defects were identified during device inspection: a-rubber glue (bending section) noted lifted.Deep scratches on switch #1 was observed.Scratch on control body noted.Minor play observed on control knob.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Internal defects of the channel , foreign object inside channel was reported.The issue found during reprocessing.There was no patient involvement on this reported event.No harm was reported, no user injury reported due to the event.

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 foreign material reported in the channel could not be identified.A definitive root cause of the issue could not be determined, as there was no device deformation that might contribute to the retention of foreign material and it is unknown if the facility device reprocessing was implemented in accordance with the ifu.The event may be detected by following the instructions for use section below: -inspection of the endoscopic system.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: 16766142
• MDR Text Key: 313569087
• Report Number: 9610595-2023-06318
• 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: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• 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: 03/29/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2013
• 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