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

Model Number TJF-160VR

Device Problems Material Twisted/Bent (2981); Material Split, Cut or Torn (4008); Failure to Clean Adequately (4048)

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

Event Date 07/28/2022

Event Type  malfunction  

Event Description

The olympus field service engineer (fse) reported (on behalf of the customer) that the evis exera duodenovideoscope had a broken elevator wire.The event was found during the procedure.There is no report of patient harm or injury associated with this event.The device was returned and evaluated, and there was found to be dirt around the forceps elevator, and the forceps elevator had a cut with a bent part.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

Manufacturer Narrative

Initial reporter name and address: establishment name: the (b)(6) postgraduate institute of medical sciences (fully documented here, to account for character limitations in the respective field).The device was returned for evaluation, and the allegation was not confirmed.There is dirt around the forceps elevator, and forceps elevator wire is bent with a cut.Additional findings are as follows: the objective lens has a scratch, light guide lens has a scratch, the adhesive on the bending section cover is detached, the bending section cover is also discolored, the connecting tube has a wrinkle, there was low angle noted, the image guide has a scratch, the control unit has a scratch, the scope cover has a scratch with discoloration, the grip has a scratch, the suction cylinder is shaved, the forceps channel port is shaved, switch button one has a scratch, the protector on the universal cord on the control section side has a scratch, the protector on the control section side of the universal cord is shaved, the universal cord has a scratch, the protector of universal cord on the suction connector side has a scratch, the suction connector has a scratch, and the light guide cover glass has a dent.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the foreign material was insufficient cleaning caused by the damaged k wire.The k-wire became snapped due to fatigue breakdown from repeated operation of the forceps elevator, then the k-wire became raised resulting from repeated reprocessing around the forceps elevator or attachment/detachment of distal cover.Identification of the foreign material could not be determined.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to correct information provided in the initial medwatch report, to provide additional information that was received from the user facility and to provide information that was inadvertently left out of the supplemental medwatch.Additional information obtained identifies that reprocessing was stopped in midway and the device was sent to olympus repair center.The suggested event is detectable and preventable by handling the scope in accordance with the following sections of the instructions for use: the detection method is described in the instruction manual evis exera tjf type 160vr operation manual chapter 3 preparation and inspection inspection of the forces elevator mechanism.Preventive measures are described in the instruction manual evis exera tjf type 160vr endoscope reprocessing manual chapter 3 cleaning, disinfection and sterilization procedures brushing around the forceps elevator and instrument channel outlet.Per the legal manufacturer, the other device defects included in the initial mdr have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.

Event Description

Correction to information provided in the initial report: as per additional information received from the user facility, the reported event (broken elevator wire) was found during reprocessing.There was no patient or procedure involvement.

• Brand Name: EVIS EXERA 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16613652
• MDR Text Key: 312407614
• Report Number: 9610595-2023-05009
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K024033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-160VR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2011
• 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