MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO BRONCHOSCOPE 1.2C 3.8TP 600L

Model Number EB-1170K

Device Problems Fracture (1260); Failure to Eject (4010)

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

Event Date 01/19/2022

Event Type  malfunction  

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.

Event Description

A cleaning brush stuck in the op-channel.This event occurred at the time of reprocessing.There was no report of patient harm.

Manufacturer Narrative

Evaluation summary: we checked the returned unit and confirmed that the remote control buttons cut.Based on the result, we concluded that it was caused due to the excessive force applied on the remote control buttons.Correction information: g6: follow up #1 h6: coding changed based on the investigation result additional information: h4: device manufacture date.

• Brand Name: PENTAX
• Type of Device: VIDEO BRONCHOSCOPE 1.2C 3.8TP 600L
• 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: 13339100
• MDR Text Key: 285014889
• Report Number: 9610877-2022-00153
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K131028
• 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: 03/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EB-1170K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/18/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1