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

Model Number	ENF-T3
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
An olympus representative reported on behalf of the customer that the rhino-laryngofiberscope had peeling of the outer surface of the insertion part.The device was returned for evaluation.During the device evaluation, the following reportable malfunction was found: the resin part of the image guide flexible pipe has 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.
Additional Manufacturer Narrative
The device was returned to olympus for evaluation, and the customer's allegation was not confirmed.During the evaluation it was found that part of the connecting tube is fallen off.Additional evaluation findings were as follows: the connecting tube has a cut, due to a cut on connecting tube, water tightness is lost, the light guide rod, control unit both has a crack, the light guide connector, free engage lever (sp), the angulation lever, the up/down plate, the grip, the diopter ring, the eyepiece, the universal cord, all has a scratch, the control unit, the connecting tube both has discoloration, the light guide rod has a burr, the universal cord has a dent, due to damage on channel tube, channel cleaning brush cannot be inserted smoothly, due to damage on channel tube, forceps cannot be inserted smoothly, due to wear of angle wire, bending angle in up direction does not meet the standard value, the connecting tube has a dent, due e to damage on image guide bundle, the image has a stain, and the image guide bundle has significant breakages.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
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.Based on the results of the investigation, a definitive root cause of the reported insertion tube coating peeling issue could not be determined, however, the issue was likely the result of physical stress and or external factors.The event can be detected/prevented by following the instructions for use which state: ¿an endoscope is a precision medical device and is designed to be used at a level that does not cause damage to the patient's body.Abnormal resistance during insertion, angle operation, etc.Is a danger signal, and stoppers installed at various functions indicate the limits of the device.Please avoid applying any more force than that¿.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: 17862050
• Report Number: 3002808148-2023-10668
• Device Sequence Number: 12188755
• Product Code: EOB
• UDI-Device Identifier: 04953170411076
• UDI-Public: 04953170411076
• 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): 11/06/2023

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: 09/10/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 10/03/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2005
• 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
• Patient Sex: Unknown