MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DUODENOVIDEOSCOPE

Model Number TJF-150

Device Problems Device Reprocessing Problem (1091); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/20/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus (b)(4) but has not returned to omsc.Olympus (b)(4) checked the subject device and found the reported phenomenon.The subject device is currently undergoing evaluation at olympus (b)(4).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 during the incoming inspection for repair at olympus (b)(4), that it was found there was the foreign object on the forceps elevator of the subject device.The subject device had been returned to olympus (b)(4) for repair of the broken forceps elevator wire.There was no patient injury associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was inspected at olympus india.It was confirmed that there was the foreign object on the forceps elevator of the subject device and it was looked that it may have occurred due to insufficient cleaning or handling problem.In addition, olympus medical systems corp.(omsc) checked the inspection report and its photo of olympus india.It was found a sign of insufficient or incorrect reprocessing the subject device that the foreign material remained on the forceps elevator of the subject device (the user may have used the poor reprocessing subject device for next procedure).The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 19-sep-2021.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 been over 7 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the k-wire was broken, and the forceps elevator did not work so reprocessing under forceps elevator was insufficient, leaving foreign material.Therefore, the brushing around the forceps elevator differed from the recommendation.A definitive root cause cannot be identified.This information is addressed in the instructions for use (ifu): all channels of the endoscope, including the elevator wire channel where fitted, must be cleaned and high-level disinfected or sterilized during every reprocessing cycle, even if the channels were not used during the previous patient procedure.Otherwise, insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection-control risk to the patient and/or operators performing the next procedure with the endoscope.¿ ¿manual cleaning: brush the forceps elevator¿.¿thoroughly clean and high-level disinfect or sterilize the endoscope before returning it for repair.Improperly reprocessed equipment presents an infection control risk to each person who handles the endoscope within the hospital or at olympus.¿ olympus will continue to monitor the field performance of this device.

• Brand Name: 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12764030
• MDR Text Key: 282008533
• Report Number: 8010047-2021-14197
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170307553
• UDI-Public: 04953170307553
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2022

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 Model Number: TJF-150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/07/2021
• Supplement Dates Manufacturer Received: 12/27/2021; 06/13/2022
• Supplement Dates FDA Received: 01/23/2022; 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• 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