MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBER NASO PHARYNGO LARYNGOSCOPE

Model Number FNL-10RBS

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

This device is classified as import for export, therefore 510k is not applicable.Model fnl-10rp3 is available in the usa with a 510k number k951196.We checked the returned unit and confirmed that the bending rubber perforated, insertion flexible tube (ift) inside of the cable became to "spiral closer" condition, bending rubber leaky.Based on the result, we concluded that the image guide fiber bundle (cfb) fluid damage was caused due to the bending rubber leaky; however, other failure is not related to the alleged complaint.

Event Description

The time of event is unknown.There was no report of patient harm.Fiber image failure(broken).

• Brand Name: PENTAX
• Type of Device: FIBER NASO PHARYNGO LARYNGOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12629685
• MDR Text Key: 281131495
• Report Number: 9610877-2021-50064
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FNL-10RBS
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1