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

Model Number TJF-Q190V

Device Problems Material Separation (1562); Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.The olympus sales rep for this account visited the facility to trouble shoot the problem reported.In speaking to the staff regarding the application of the distal cap prior to the procedures, it was identified there may have been user error involved.The user forcefully applied the caps.The staff was re-educated regarding the proper application of the cap, and there have been no further issues reported.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported during an unspecified procedure using an evis exera iii duodenovideoscope, when the scope was being removed from the patient, the cap fell off into the patient's mouth (and was retrieved).There were minor scratches in the patient's esophagus the physician believes were caused by the scope.No medical or surgical intervention was required as a result of this occurrence.Multiple attempts were made to gather additional details regarding the patient and reported event with no response from the customer.

Manufacturer Narrative

This report is being updated to provide additional information provided by the customer.New information is reported in h7, h9, and h10.Corrected information is reported in b5, h6 h6: device problem: physician felt the outer diameter of the device was bigger than it should be.Correction and preventative action (capa ) investigation has been opened to further investigate this issue.

Event Description

New information provided by the customer: the procedure was aborted because the physician felt that the outer diameter was bigger than the current ercp scope tjf-q180.The cap did not fall off in this procedure.There was no scratch to the patient's esophagus.

Manufacturer Narrative

Upon further review this is not a reportable device malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to a death or serious injury if the malfunction were to recur.

• Brand Name: EVIS EXERA III DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11655293
• MDR Text Key: 245408251
• Report Number: 8010047-2021-04892
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170405563
• UDI-Public: 04953170405563
• Combination Product (y/n): N
• PMA/PMN Number: K202661
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2021

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: TJF-Q190V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 04/13/2021
• Supplement Dates Manufacturer Received: 04/21/2021; 05/21/2021
• Supplement Dates FDA Received: 05/14/2021; 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1292-2021
• Patient Sequence Number: 1
• Treatment: MAJ-2315