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

Model Number CF-H190I

Device Problem Insufficient Information (3190)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to omsc for evaluation but was returned to olympus (b)(4) (ofr).Ofr checked the subject device and found that the reported phenomenon that the distal end was damaged (crack, scratch, dent, chipped, not burnt, missing part and traumatic).In addition, ofr found also the glue of the bending rubber was deterioration separation, shave and white-clouded.The insulation electrical test of distal end was failed.Ofr surmised that the damage of the distal end was caused by shock or crushing to the distal end and probably already existed before the procedure on the patient.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed from the user that during an unspecified procedure, it was found that the distal end cover cracked, sharp edge, traumatic for the patient, the endoscope caused the patient bleeding.The information regarding the patient¿s outcome could not be obtained.The occurrence date of the event is unknown.

Manufacturer Narrative

This supplemental report is being submitted to provide the subject device evaluation result.The subject device was returned to olympus france (ofr).Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity.Ofr requested the facility four times to provide the information regarding the patient, however the facility did not provide and ofr could not obtain it.The exact cause of the reported phenomenon could not be conclusively determined.However, based upon the information from ofr, the instruction for use (ifu), and past similar case, omsc surmised that the reported phenomenon was attributed to following.The user hit the distal end of the subject device during other than the procedure and the distal end cover broke.In addition, the user's pre-use inspection was insufficient and the subject device was used in the procedure.

Manufacturer Narrative

This supplemental report is being submitted to provide a correction to a1, d8, and g2 to include information that was inadvertently not included on the previous submissions.A correction was also made to d9 (date returned to manufacturer) to reflect the correct date.In addition, h6 code (type of investigation) "4109" has been added as it was inadvertently not included on the previous submission.H6 code (investigation findings) has been corrected to "4248" and "3243," and h6 code (investigation conclusions) has been corrected to "4315.".

• Brand Name: EVIS EXERA LLL 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: 12511135
• MDR Text Key: 272656131
• Report Number: 8010047-2021-12115
• Device Sequence Number: 1
• Product Code: FDF
• UDI-Device Identifier: 04953170305177
• UDI-Public: 04953170305177
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CF-H190I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• 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
• Patient Sex: Female