MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBEROPTICBRONCHOSCOPE 2.0C 4.8TP RO PLS

Model Number FB-15RBS

Device Problem Fracture (1260)

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

Event Date 12/07/2021

Event Type  malfunction  

Event Description

The root of ift was easy to crack.The time of event is unknown.There was no report of patient harm.

Manufacturer Narrative

This device is not distributed in the usa, therefore the pma/510(k) number is not applicable.If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Evaluation summary: the root of ift was broken, because of man-made force.The scope was repaired by the third party and returned to the hospital.Correction information: h6: coding changed, based on the investigation result.Additional information: d8: this device was serviced by a third party.

• Brand Name: PENTAX
• Type of Device: FIBEROPTICBRONCHOSCOPE 2.0C 4.8TP RO PLS
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 13173183
• MDR Text Key: 289218675
• Report Number: 9610877-2022-00069
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FB-15RBS
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1