MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. RHINO-LARYNGOFIBERSCOPE

Model Number ENF-T3

Device Problem Peeled/Delaminated (1454)

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

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the watertightness of the insertion tube was not maintained due to external factors, the insertion tube was discolored, there were wrinkles in the insertion tube, there was a stain on the image guide bundle, the curved rubber adhesive part was missing, the control unit was cracked, and the light guide rod was cracked and burr.In addition, the suction port, the eyepiece, the grip, the light guide connector, and the scope cylinder were all scratched.The investigation is ongoing and follow up with the user facility is currently being performed.

Event Description

The customer reported to olympus, the insertion part was peeling on the rhino-laryngofiberscope.Inspection and testing of the returned device found the resin part of the insertion tube had fallen off.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

Event Description

The following additional information was received from the customer: the device was used during a therapeutic pharyngeal foreign body removal procedure.A pre-use inspection of the device was performed.There was no procedural delay due to this event, and the procedure was completed with the instrument intact.The insertion part peeling was observed after reprocessing the device.

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 19 years since the subject device was manufactured.Based on the results of the investigation, it could not be determined if the fallen insertion tube was caused by stress, handling, or other issues.Therefore, the root cause could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: RHINO-LARYNGOFIBERSCOPE
• Type of Device: RHINO-LARYNGOFIBERSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15972799
• MDR Text Key: 308361068
• Report Number: 3002808148-2022-05181
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04953170050992
• UDI-Public: 04953170050992
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K011869
• 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: 01/09/2023

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: ENF-T3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2022
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2022
• Initial Date FDA Received: 12/13/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2003
• 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
• Treatment: MODEL NO. OTV-SI, SERIAL NO. (B)(4)