MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. TRACHEAL INTUBATION FIBERSCOPE

Model Number LF-P

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

The customer reported to olympus, a torn tip on the tracheal intubation fiberscope.There was no report of user or patient harm associated with this event.During inspection of returned device, it was observed the bending section cover had fallen off.This mdr is being submitted to capture the reportable malfunction found during evaluation.

Manufacturer Narrative

The subject device was returned to olympus for evaluation.During inspection and testing, the allegation was confirmed.It was found, the tear of the curved rubber was caused by external factors.In addition to the evaluation in b5, there were wrinkles in the insertion tube.There was an abnormality of the image guide bundle.Fluid invaded the body control unit.There was decreased output of light from light guide.Control body was deteriorating.The insertion tube was crushed.The bending rubber was torn.Watertightness was not maintained due to tearing of the curved rubber.There were scratches on the up/down plate.The universal cord was scratched.There were scratches on the eyepiece.Additional information has been requested regarding this event.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information becomes available.

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 5 years since the subject device was manufactured.Based on the results of the investigation, it¿s likely the bending section cover fell off due to external factors or handling.The root cause of this event was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: TRACHEAL INTUBATION FIBERSCOPE
• Type of Device: TRACHEAL INTUBATION FIBERSCOPE
• 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: 15666812
• MDR Text Key: 307159796
• Report Number: 9610595-2022-03272
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170051098
• UDI-Public: 04953170051098
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K221631
• 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: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LF-P
• Device Catalogue Number: 2882730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• 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