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

Model Number PCF-H190L

Device Problem Partial Blockage (1065)

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

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation was confirmed.In addition to air/water or aspiration problem, additional findings are as follows: plastic distal end cover insulation had dents and scratches; the forceps passage had multiple kinks a distal end side; control knob on right/left and up/down knob were loose and had play; the distal plastic end cover had dents and scratches; the bending section cover glue had cracked both sides; insertion tube had minor scratches and not catching cotton; and light guide tube had scratches.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the evis exera iii colonovideoscope during insertion or removal forceps get caught, channel tightness and difficulty when passing the forceps, and trouble connecting to the clv-190, no hdmi on screen.The event occurred during a therapeutic procedure.The procedure was prolonged by thirty minutes.The minor delay posed no significant or additional ristk to the patient.There was no patient harm associated with the event.The device was returned and evaluated, and it was found that there was an air/water or aspiration problem.This mdr (medical device report) is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

This supplemental report is to correct the initial mdr.The initial medwatch reported the subject device had channel tightness and difficulty passing forceps while using the colonovideoscope to remove a polyp were observed.It also had trouble connecting to the clv-190.The procedure was prolonged by 30 minutes.The patient and the outcome of the procedure were not impacted.No additional medical intervention was required.The minor delay poses no significant or additional risk to the patient.No injury or harm was reported.There is no evidence that a life-threatening event occurred, that the malfunction caused or contributed to a permanent impairment in the patient, or that additional medical or surgical intervention was required to preclude permanent impairment.Additionally, the customer confirmed they do not inspect the biopsy valve with the accessory prior to use.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 17484223
• MDR Text Key: 320711765
• Report Number: 9610595-2023-11359
• Device Sequence Number: 1
• Product Code: FDF
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PCF-H190L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2015
• 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