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

Model Number	ENF-T3
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3002808148-2022-05181
• Device Sequence Number: 20359321
• Product Code: EOB
• UDI-Device Identifier: 04953170050992
• UDI-Public: 04953170050992
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 12/13/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2003
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MODEL NO. OTV-SI, SERIAL NO. (B)(4)
• Patient Sex: Unknown