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

Model Number CF-H170L

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 03/29/2023

Event Type  malfunction  

Manufacturer Narrative

During the device evaluation, the following observations were noted: the angle wires were stretched, part of the insertion tube was caught and pinched, the resin on the insertion tube was cracked due to chemical stress applied during reprocessing, the light guide lens was chipped due to insufficient handling, the resin at the distal end was cracked, and the insertion tube was perforated.Per the legal manufacturer, these other issues identified by service have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, the colonovideoscope handle was rigid and there was metal coming out of the tip.There were no reports of patient or user harm associated with this event.The subject device was received at an olympus service center for evaluation.Upon inspection and testing, it was discovered that a cut portion of the metal insertion tube braid/strand was protruding from the inside.This report is being submitted to capture the malfunction found during the device evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation (h6/h10).The device was returned to olympus for inspection, and the customer's complaint was confirmed.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 is likely physical stress was applied to the insertion section while the user was handling the device, which damaged the braids inside the section, and resulted in the reported event.Three attempts were performed to obtain additional information, but no response was received from the customer.The event can be prevented by following the instructions for use (ifu) which state: "·important information ¿ please read before use_ warnings and cautions :do not strike, hit, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video cable, video connector, or light guide connector.Also, do not bend, pull, or twist the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, video cable, video connector, or light guide connector with excessive force.The endoscope may be damaged and could cause patient injury, burns, bleeding, and/or perforations.It could also cause parts of the endoscope to fall off inside the patient.:do not coil the insertion tube, universal cord, or video cable with a diameter of less than 12 cm.Equipment damage may result.·chapter 4 operation_ 4.2 insertion_ insertion of the endoscope :do not allow the insertion section to be bent within a distance of 10 cm or less from the junction of the boot.Insertion section damage can occur.Ifu: gif/cf-170 series reprocessing manual ·chapter 5 reprocessing the endoscope (and related reprocessing accessories)_ 5.1 summary of reprocessing the endoscope :to prevent damage, do not coil the insertion tube, the universal cord, or video cable of the endoscope with a diameter less than 12 cm." olympus will continue to monitor field performance for this device.

• Brand Name: 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: 16829988
• MDR Text Key: 314168191
• Report Number: 9610595-2023-06836
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170334160
• UDI-Public: 04953170334160
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-H170L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• 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