MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO BRONCHOSCOPE

Model Number EB19-J10

Device Problems Fracture (1260); Melted (1385)

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

Event Date 10/01/2021

Event Type  malfunction  

Manufacturer Narrative

If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Distal body melted, burned with a laser.The time of event is unknown.There was no report of patient harm.

Manufacturer Narrative

Evaluation summary: we checked the returned unit and confirmed that the operation channel leak.Based on the result, we concluded that it was caused due to the excessive force applied on the operation channel; however, other failure is not related to the alleged complaint.

• Brand Name: PENTAX
• Type of Device: VIDEO BRONCHOSCOPE
• 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: 12701571
• MDR Text Key: 284114363
• Report Number: 9610877-2021-01220
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K200678
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EB19-J10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1