MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II COLONOVIDEOSCOPE

Model Number CF-H180AL

Device Problems Crack (1135); Restricted Flow rate (1248); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The scope was returned to the service center for evaluation.The customer¿s complaint of a ¿ clogged intel¿ was confirmed as the nozzle and auxiliary water flow was found clogged.Due to this the water was found to mix with the air.The bending section rubber and bending section glue were found cracked resulting in a leak at the insertion tube side of the scope.The plastic scope cover was noted to be dented.Further inspection found excessively frayed wire on the scope¿s bending section.The insertion tube was found buckled with minor scratches.A pinhole was found in the cement glue of the objective lens.The scope¿s image was checked and found tilted 10 degrees left.The #3 camera switch was found chipped.There was minor discoloration on the scope¿s control body.Buckles were noted on the light guide tube.The scope connector was found loose.The scope¿s control knob movement was check and loose play was noted.The scope¿s id chip displayed a total usage count of 3045.

Event Description

The user facility reported during reprocessing the scope¿s intel was noted to be clogged.There was no patient involvement.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g4, g7, h2, and h10.The user facility confirmed the auxiliary water channel was clogged.There was no foreign material exiting the scope.This supplemental report is to inform that upon further review, the reported issue and the issues identified by the service center (as outlined in the initial report) are not reportable malfunctions.Per the legal manufacturer, there is no potential for these issues to cause or contribute to death or serious injury if the malfunctions were to recur.

• Brand Name: EVIS EXERA II COLONOVIDEOSCOPE
• Type of Device: COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11028437
• MDR Text Key: 222103317
• Report Number: 8010047-2020-10574
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170202445
• UDI-Public: 04953170202445
• Combination Product (y/n): N
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-H180AL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 01/17/2021
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1