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)

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

Event Date 08/05/2022

Event Type  malfunction  

Manufacturer Narrative

The device is returned and an evaluation completed for it.Upon inspection of the device, it was observed that it was observed that the forceps elevator coil (k-wire) was cut with a part bent.This is likely caused by mechanical or chemical stress caused by long term use.Other observations for the device are: due to wear of angle wire, the play of up/down/left/right knobs and bending angle do not meet the standard value; connecting tube, universal cord, and control unit have a scratch; and grip and suction cover (s-cover) has a dent.The user¿s complaint of broken elevator wire being broken was confirmed.Evaluation is ongoing.Supplemental report(s) will be submitted when any relevant new information is available.

Event Description

Customer returned the device for evaluation and repair of the low angulation issue and elevator wire broken observed during reprocessing.There is no patient involvement and no harm reported to any patient.Upon evaluation of the returned device, it was observed that the forceps elevator coil (k-wire) was cut with a part bent.This medwatch is being submitted for the reportable issue of the k-wire being cut and bent as observed during device evaluation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The customer later confirmed the broken elevator wire was observed during reprocessing.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 reported event is unable to be determined.However, the cause of the event is likely due to wear of k-wire by repeated operation of the forceps elevator resulted in the wire being snapped.It is also likely the snapped wire was caught in the distal cover when the cover was attached to the device or, the snapped wire was contacted by the cleaning brush during the brushing process on the distal end and got frayed.The event can be detected by following the instructions for use (ifu) which state: 3.2 inspection of the endoscope: inspection of the forceps elevator mechanism: inspection for smooth operation: ¿visually confirm that the portion of the elevator wire extending from the distal end of the endoscope is not broken, frayed, or bent (see figure 3.5).If any damage (broken, frayed, or bent portion) is observed on the elevator wire as shown in figure 3.5, do not use the endoscope.¿ 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 Contact: masaharu hirose ; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8-520 ; JA 965-8520 ; 426422891
• MDR Report Key: 15400708
• MDR Text Key: 306257749
• Report Number: 9610595-2022-01722
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

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 Operator: Health Professional
• Device Model Number: TJF-160VR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/17/2022
• Initial Date FDA Received: 09/12/2022
• Supplement Dates Manufacturer Received: 09/28/2022
• Supplement Dates FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2008
• 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