MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; LINEAR ULTRASOUND VIDEOBRONCHOSCOPE 2.0C

Model Number EB-1970UK

Device Problem Obstruction of Flow (2423)

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

Event Date 06/09/2022

Event Type  malfunction  

Manufacturer Narrative

We checked the returned unit and confirmed that the operation channel stuck accessory/object.Based on the result, we concluded that it was caused due to the insufficient reprocessing at the facility on the operation channel.In addition, we confirmed that the u/d knob loose, the light guide cable for control body loose, the distal body worn out, the insertion flexible tube (ift) dented, and the biopsy inlet t-piece broken accessory blocking inside biopsy t-piece; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0588(channel)"" and/or the risk analysis results, it was evaluated to submit mdr.

Event Description

The time of event is unknown.There was no report of patient harm.Operation/suction channel clogged.

• Brand Name: PENTAX
• Type of Device: LINEAR ULTRASOUND VIDEOBRONCHOSCOPE 2.0C
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645
• MDR Report Key: 14882466
• MDR Text Key: 303574380
• Report Number: 9610877-2022-54623
• Device Sequence Number: 1
• Product Code: EOQ
• UDI-Device Identifier: 04961333148226
• UDI-Public: 04961333148226
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131946
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EB-1970UK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2022
• Initial Date FDA Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1