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

Model Number LF-DP

Device Problem Peeled/Delaminated (1454)

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

Event Type  malfunction  

Manufacturer Narrative

The device was returned and the evaluation found the following: due to a pinhole on bending section cover or distal sheath rubber, water tightness is lost; due to a pinhole on connecting tube, water tightness is lost; connecting tube has coating peeling.(1mm2 or more); due to a dent on channel tube, suction volume does not meet the standard value; adhesive on bending section cover or distal sheath rubber is detached; due to a dent on bending tube, bending angle in upwards direction exceeds the standard value; due to a dent on channel tube, channel cleaning brush cannot inserted smoothly; light guide bundle has breakage; connecting tube is snaking; connecting tube has a dent; indication on light guide connector is unclear; angulation lever has stain; control unit has discoloration; venting connector under grip has a dent; the evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was observed during the device evaluation that the tracheal intubation fiberscope image guide coat was peeling.There were no reports of patient involvement.

Manufacturer Narrative

Updated fields: h6 this report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Since the device is more than 15 years old, the device history record was unable to be reviewed.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, a definitive root cause could not be determined.It is likely the reported event was caused by stress from repeated use, external factors, or handling.The event can be detected by handling the device in accordance with the following instructions for use (ifu): chapter 3 preparation and inspection 3.2 preparation and inspection of the endoscope 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 (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: 18912744
• MDR Text Key: 337763516
• Report Number: 9610595-2024-05541
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04953170340192
• UDI-Public: 04953170340192
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K981543
• 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: 04/02/2024

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: LF-DP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/1998
• 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