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

Model Number JF-260V

Device Problem Crack (1135)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.It was found that the air/water supply volume did not meet the standard value due to clogging of the nozzle.In addition to the gap found in the adhesive area between the plastic cover and the distal end, other evaluation findings are as follows: the bending angle in the up direction did not meet the standard value due to wear of the angle wire; the play of the upward/downward knob was out of standard value due to wear of the angle wire; the adhesive on the bending section cover had a chip; the water removal ability did not meet the standard value due to clogging of the nozzle; the indication on the suction connector was peeled; the suction cylinder was shaved; and the electrical connector had discoloration due to water leakage.Lastly, there were scratches on the following parts: the bending section cover adhesive, the connecting tube, the plastic distal end cover, the distal end, the protector of the universal cord on the suction connector side, the forceps elevator lever, the forceps elevator knob, the upward/downward knob, the right/left knob, the switch box, the suction connector, the universal cord, the grip, and the control unit.A review of the device history record found no deviations that could have caused or contributed to the reported issue.There was no indication that the event was caused by a misuse or that the event was related to design of the device.Repair history was reviewed and no issues were found related to the reported event.The device was not repaired within the past year.Although it was determined that the defect was likely caused by stress of repeated use, external factors, or handling, a definitive root cause of the gap in the adhesive could not be identified if additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor the field performance of this device.

Event Description

The customer reported to olympus that the evis lucera duodenovideoscope had poor air/water supply.There was no report of patient harm.The device was returned, evaluated, and a gap was found between the adhesive part of the plastic cover and the distal end of the device.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.

• 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 (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17219324
• MDR Text Key: 318339522
• Report Number: 9610595-2023-09431
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/28/2023

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: JF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2002
• 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