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

Model Number	ENF-GP2
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus for evaluation.During inspection and testing, the allegation of camera head or tip getting stuck when articulating was not confirmed.The allegation of insufficient angulation was not confirmed.The angulation was within standards.In addition, the bending section was not loose and did not have dents.Visual inspection of the distal end and bending section of the insertion portion appeared normal as there were no damages, no sharp protrusions or edges.The insertion tube did not have any kinks or bends.No abnormalities were discovered when inspecting the handle or a-lever.The bending section and angle lever moved smoothly without uneven rotation, squeaking, roughness, play, noise, or unusual motion.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
A physician reported to olympus, the rhino-laryngo fiberscope could not angulate sufficiently, and the camera head or tip was getting stuck when articulating.The event occurred during a diagnostic nasal and laryngeal endoscopy.The procedure was only prolonged by a few additional seconds.The event although intermittent, is occurring with more frequency.At times, either flexing or extending the scope tip using the thumb toggle, the tip will stick in a fully flexed or extended position.The physician believes the issue is related to the distal aspect of the scope/tip or the operating thumb toggle.When the scope is passed through a patient's nose, flex the tip to move down past the nasopharynx and visualized the glottis, the malfunction occurs at this portion of the exam.The physician is forced to retract the flexible scope back through the nasopharynx and nasal passage with the inability to straight the tip which resulted in discomfort for the patient.There was no patient harm or injury associated with this event.
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, the root cause of the reported event is unable to be determined.The event can be detected by following the instructions for use (ifu) which state: " -before transnasal insertion, apply the appropriate pretreatment and lubrication to the patient to enlarge the nasal cavity.Otherwise, patient injury can result, or the endoscope could become lodged and be difficult to withdraw.When applying a pretreatment agent through a tube, insert the tube into the same path as the path planned for the endoscope¿s insertion.Otherwise, the treatment will have no effect.-the effects of the pretreatment agent and lubricant will decrease as the procedure lasts longer.Apply the pretreatment agent or lubricant as required during the procedure ¿ for example, when withdrawal seems to be difficult.-if any of the following conditions occur during an examination, immediately stop the examination and withdraw the endoscope from the patient as described in section 5.3, ¿withdrawal of the endoscope with an irregularity¿.Olympus will continue to monitor field performance for this device.

• Brand Name: RHINO-LARYNGO FIBERSCOPE
• 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: 16402843
• Report Number: 3002808148-2023-01580
• Device Sequence Number: 5632388
• Product Code: EOB
• UDI-Device Identifier: 04953170399282
• UDI-Public: 04953170399282
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K181240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2023

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-GP2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 03/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• 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