MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. COLONOVIDEOSCOPE

Model Number CF-V70I

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 05/18/2022

Event Type  malfunction  

Manufacturer Narrative

During inspection and testing, service also found the angulation was insufficient due to wear of the angle wires.The insertion tube was wrinkled and scratched.The switch box was scratched, and switch #1 had dirt.The investigation is ongoing; therefore, the root cause of the internal metal braiding protruding from the insertion section cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported the angle of the subject device was tight.The issue was observed when preparing the device for use, prior to a diagnostic enteroscopy procedure.There was no delay in the procedure due to the issue.Another similar device was used to complete the intended procedure.There was no patient or user injury reported due to the event.The device was returned to an olympus service center for evaluation.During the inspection and testing of the returned device, service found there was internal metal braiding protruding from the insertion section.This report is being submitted for the malfunction found by service during the device evaluation (metal protruding).

Manufacturer Narrative

This report is being supplemented to provide additional information.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the investigation, possible causes may include the following: insertion section was damaged by physical stress/chemical stress/storage environment and braid inside insertion section cut.As a result, the strand protruded out.A definitive root cause cannot be identified.This issue is covered in the instructions for use: preparation and inspection: inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, scratching, holes, sagging, transformation, bends, adhesion of foreign bodies, dropout of parts, any protruding objects or other irregularities.Do not strike, bend, hit, pull, twist, or drop the endoscope¿s distal end, insertion tube, bending section, control section, universal cord, or endoscope connector of the endoscope 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.If necessary, apply a medical-grade, water-soluble lubricant to the insertion tube.Compatible reprocessing methods and chemical agents: detergent solution: use a medical-grade, low-foaming, neutral ph detergent or enzymatic detergent and follow the manufacturer¿s dilution and temperature recommendations.Contact olympus for the names of specific brands that have been tested for compatibility with the endoscope.Do not reuse detergent solutions.The storage cabinet must be clean, dry, well ventilated and maintained at ambient temperature.Storing the endoscope in direct sunlight, at high temperatures, in high humidity or exposed to x-rays and ultraviolet-rays may damage the endoscope or present an infection control risk.Olympus will continue to monitor the field performance of this device.

• Brand Name: 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14724236
• MDR Text Key: 302186387
• Report Number: 8010047-2022-10219
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-V70I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2012
• 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