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

Model Number CF-HQ190L

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Pain (1994)

Event Date 04/22/2022

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation.The investigation is in process.The olympus service center evaluated the device and identified the following: the up/down knob was clicking, angulation control knob had play, the plastic distal end cover had minor dent and scratches, the objective lens had internal crack, the bending section cover glue was cracked, and the insertion tube had minor deformation.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer under this mdr report number 2951238-2022-00409.

Event Description

The customer reported to olympus the physician injured his left hand during a prolonged colonoscopy which required significant manipulation of the scope wheels.The scope wheels (both big and small wheels) were unusually rigid and required a significant amount of extra force to turn.The subject device was not inspected prior to the procedure.The procedure was completed with the same device.The physician's left hand injury was treated with three sessions at the chiropractor, therabath (hot paraffin wax bath) nightly, three sessions of physical therapy, and ibuprofen.The physician's hand is no longer in pain due to the extensive therapy however it continues to feel fatigued.

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.It has over 2 years since the subject device was manufactured.Based on the results of the investigation, it was confirmed that the torque values of the angulation control knobs were measured in three rounds, of which one round failed to meet the specification (down direction in free condition and up direction in engage condition).This likely caused the user reported event of ¿tight angulation control knob.¿ due to this issue, the doctor had to overuse his hand, which likely resulted in the reported injury.However, the root cause could not be determined.This supplemental report includes information added to d8.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III 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: 14497439
• MDR Text Key: 293263221
• Report Number: 8010047-2022-08859
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• 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: 04/28/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2020
• 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
• Patient Outcome(s): Required Intervention; Other