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

Model Number TJF-260V

Device Problem Mechanical Jam (2983)

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

Event Date 08/29/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, the reported issue (forceps elevator would not return) was not confirmed or duplicated.In addition, service found the bending angle was out of specification due to wear of the angulation wire, the suction cylinder was scraped, and there was water coverage on the electrical connector.Scratches were observed on the control section, the tip cover, the insertion part corrugated tube protector, the control section cover, the right/left knob, the grip, the universal cord, the scope connector side of the universal cord, and the scope connector due to external factors.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported the forceps elevator would not return after being raised.Reportedly, after operating the knob several times, the forceps elevator returned.There was no patient or user injury reported due to the event.Additional details have been requested regarding the reported issue.At this time, no additional information has been provided.

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 7 years since the subject device was manufactured.Based on the results of the investigation, it is likely that the forceps elevator was temporarily caught due to external factors, such as hitting, etc., or something was likely temporarily caught in the forceps elevator which caused the forceps elevator not to move down when operating the forceps lever.However, the root cause could not be determined.This supplemental report includes information added to event.Also, correction made to date of event from initial medwatch.Olympus will continue to monitor field performance for this device.

Event Description

The following additional information was received from the customer: the reported malfunction was identified during a pre-use inspection.There was no delay in the procedure or clinical impact to the patient due to this issue.

• Brand Name: EVIS LUCERA 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: 15508807
• MDR Text Key: 306325494
• Report Number: 9610595-2022-02400
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/31/2022
• Initial Date FDA Received: 09/29/2022
• Supplement Dates Manufacturer Received: 10/07/2022
• Supplement Dates FDA Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2015
• 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