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

Model Number CF-HQ190L

Device Problem Partial Blockage (1065)

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

Event Date 05/08/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, they were not able to get the forceps through the evis exera iii colonovideoscope.The issue was found during preparation for use.There were no reports of patient harm.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed, the device evaluation found that a brush was passed through the forceps passage with no restriction; however, a leak was found on the instrument channel and a second dunk test was unable to be performed.Additional findings include the following: the labeling was scratched / was peeling, the camera had a hole on switch 1, the forceps passage was kinked / scraped / had tear marks, the angulation was below standard, the control knob had excessive play, the control knob movement clicked when the lock engaged, and the insertion tube had shakiness.The following parts were determined to be serviced by a third party (non-olympus parts): forceps passage channel, plastic distal end cover, objective lens glue, light guide lens glue and lenses, bending section cover, bending section cover glue, insertion tube, control body (non-olympus repair), light guide tube, and scope connector (non-olympus wet / dry sticker found).The investigation is ongoing, a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

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, a definitive root cause could not be established.The suggested phenomenon could not be further specified from the following investigative results: device inspection detected a kink and leakage from the biopsy channel.The subject device was third-party repaired.Despite 3 gfe (good faith attempts), the user did not reply to inquiry by olympus.Further information was unavailable.Therefore, a further cause of the suggested phenomenon could not be presumed.Inspection results confirmed leakage from the biopsy channel - therefore, it was confirmed that the device did not satisfy its specification or function.The suggested event is detectable/preventable by handling the device in accordance with the following instructions for use (ifu): ifu: gif/cf/pcf-190 series operation manual chapter 3 preparation and inspection states detection method.Ifu: gif/cf/pcf-190 series reprocessing manual chapter 5 reprocessing the endoscope states preventive measures.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: 17073627
• MDR Text Key: 317486883
• Report Number: 9610595-2023-08472
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170305115
• UDI-Public: 04953170305115
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-HQ190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2017
• 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