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

Model Number TJF-160VR

Device Problem Material Frayed (1262)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to an olympus repair center for evaluation and the customer¿s reported problem of the wires being completely cut was unable to be confirmed during the evaluation however it was found that some of the wires that composes the forceps elevator wire were raised due to cut or fray.It was found that the adhesive on the rubber covering the bending section was detached.In addition, the device evaluation found that the connecting tube had a wrinkle, the angle wire was stretched, and knob had play in it.Scratches were found on the grip, connecting tube, universal cord, lens glass (lg) cover glass, scope connector and protector of universal cord on control section side.It was also found that the switch had a pinhole.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus, the forceps elevator wire (k-wire) was completely cut off.There were no reports of patient harm.

Manufacturer Narrative

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 12 years since the subject device was manufactured.Based on the results of the investigation, it is likely the k-wire (knob-wire) being cut with a bent part occurred due to fatigue breakdown from repeated manipulation of forceps elevator, and then k-wire raises by repeated brushing around the elevator and attaching / detaching distal cover.However, a definitive root cause could not be determined.The following information is stated in the instructions for use (ifu): ¿evis exera tjf type 160vr operation manual includes the detection way in chapter 3 preparation and inspection of the forceps elevator mechanism.Evis exera tjf type 160vr endoscope reprocessing manual the preventive measures in chapter 3 cleaning, disinfection and sterilization procedures brushing around the forceps elevator and instrument channel outlet.¿ olympus will continue to monitor field performance for this device.

• 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: 16965279
• MDR Text Key: 315591846
• Report Number: 9610595-2023-07759
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• 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: 04/19/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2010
• 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