MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

Device Problems Contamination (1120); Mechanical Jam (2983); Failure to Clean Adequately (4048)

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

Event Date 06/09/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being supplemented to provide a correction and device evaluation details.Updated with correct reportable malfunction.Per the legal manufacture, the forceps elevator not moving in any direction at all will not cause or contribute to death or serious injury if the malfunction were to recur.Corrected the medical device problem code.Device evaluation found the following technical defects: the adhesive on the bending section cover has a scratch and is dirty, the connecting tube has a cut and is wrinkled, the scope connector cover has a scratch, the universal cord has discoloration, the image guide protector is shaved, the angle wire, bending angle in up/down/left/right direction and play do not meet the standard, the forceps do not rise up at all and the plastic distal end cover has a scratch.

Event Description

Upon inspection and testing of the customer returned device, it was observed that the forceps elevator has foreign material.This report is being submitted for the malfunction found during evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.An olympus representative was dispatched and went onsite on 21jun2022 to review reprocessing and device handling instructions with the facility.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 3 years since the subject device was manufactured.Based on the results of the investigation, the specific root cause of the foreign material could not be determined at this time.The following information is stated 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.¿ olympus will continue to monitor field performance for this device.

Event Description

As reported for this event, during reprocessing the device forceps elevator did not move in any direction at all.There is no patient involvement and no harm reported to any patient.

Manufacturer Narrative

The device is returned and an evaluation completed for it.The user¿s complaint was confirmed.Upon inspection and testing, it was observed that forceps elevator has foreign material.The forceps raiser wire (k-wire) is damaged.Damaged caused is attributed to handling issue causing mechanical/chemical stress applied by repeated use for the long duration.This caused the reported issue of no movement of the forceps elevator.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Manufacturer Narrative

Additional information has been received for this event.This supplemental report is being submitted to provide this information.Please see the updates in sections: g3, g6, h2, and h10.Customer follows correct reprocessing procedure as per olympus training and instructions for use.Customer also has all required brushes.However, in this case, the device could not be reprocessed completely (including brushing and reprocessing cycles in the automatic endoscopy reprocessor) due to the elevator issue.Generally, customer uses an olympus oer series automatic endoscopy reprocessor (sn (b)(6) with local brand detergent and disinfectant.Scopes are stored in almirah cabinet after reprocessing.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.See additional information on h6 and h10.Based on the results of the legal manufacturer's investigation, adhesion of foreign material to forceps elevator and around it was confirmed.The foreign material could not be identified and the root cause of the material remaining in the device could not be specified.From the information obtained, it was determined that reprocessing steps recommended in ifu were not completely conducted due to nonconformities of the device and insufficient handling.Performance of reprocessing of the subject device was confirmed in the following reports by conducting correct reprocessing in accordance with ifu.(cleaning/ disinfection/ sterilization) 147p-3557, 147p-6094, 147p-6093, 066-3255, 966-0198.Additionally, customer training was performed accordingly.It has been over 4 years since the subject device was manufactured.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Correction: d3, g1, h10.This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 9610595.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14919231
• MDR Text Key: 301639400
• Report Number: 8010047-2022-11344
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/15/2024

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-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/10/2022
• Initial Date FDA Received: 07/05/2022
• Supplement Dates Manufacturer Received: 06/15/2022; 07/26/2022; 02/22/2023; 03/06/2023; 05/15/2024
• Supplement Dates FDA Received: 07/13/2022; 08/04/2022; 02/22/2023; 03/30/2023; 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/19/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: Z-0379-2022
• Patient Sequence Number: 1