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

Model Number ENF-T3

Device Problem Disconnection (1171)

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

Event Type  malfunction  

Manufacturer Narrative

The subject device has been returned to olympus for evaluation.In addition to the reportable malfunction mentioned in b5, it was observed due to a cut on connecting tube, water tightness was lost, the adhesive on the bending section cover (a-rubber) had a discolored area, the connecting tube had a discoloration, due to wear of the angle wire, bending angle in up direction did not meet the standard value, the forceps could not be inserted smoothly due to damage, channel cleaning brush could not be inserted smoothly, the objective lens had discoloration, the light guide (lg) lens had discoloration, due to damage on image guide (ig) bundle, the image had a stain, the lg-rod had a crack, the lg-cover glass was dirty, the protector of universal cord on standard (s)-connector side had a scratch, the protector of universal cord on control section side had discoloration, the angulation lever had a scratch, the control unit had a scratch, and the grip and the eye piece had scratch.The investigation is ongoing, and a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported to olympus, the rhino-laryngofiberscope had defects on the insertion tube-non bending section.Upon inspection of the customer¿s returned device it was observed, part of the connecting tube of the subject device was falling off.This report is being submitted for the malfunction found during evaluation.There was no harm or user injury reported due to the event.

Manufacturer Narrative

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, the root cause of part of the connecting tube falling off was unable to be identified.The event can be prevented by following the instructions for use which state: ¿6.3 precautions concerning use of therapeutic devices.¿ olympus will continue to monitor field performance for this device.

Event Description

The customer reported to olympus, the rhino-laryngofiberscope had defects on the insertion tube-non bending section.The intended procedure was a biopsy of a laryngeal tumor.The procedure was completed.The customer uses the subject device one time per month.The customer uses phthalal for cleaning, disinfection, and sterilization.

Manufacturer Narrative

This report is being supplemented to provide a correction to b5 of the initital medwatch report.The information included in b5 was inadvertently omitted from the initial medwatch report.

• 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: 16386570
• MDR Text Key: 309666661
• Report Number: 3002808148-2023-01481
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04953170411076
• UDI-Public: 04953170411076
• 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,Followup
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2023
• 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: 01/22/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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