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

Model Number EB-1970K

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/15/2023

Event Type  malfunction  

Event Description

The time of event is unknown.There was no report of patient harm.Distal case missing.

Manufacturer Narrative

The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the distal body chipped.Based on the result, we concluded that it was caused due to the excessive force applied on the distal body.In addition, our technician confirmed that the lg prong top broken, the remote control buttons perforated, the light guide cable buckled, the objective lens cracked, the insertion flexible tube crushed, the suction arm deformed, the lg prong top loose, the angle wire hard to move, the operation channel (primary) resistance, the u/d knob white marking faded/missing, and the u/d lock lever white marking faded/missing; however, these defects are not the main cause and/or irrelevant to the alleged complaint.In terms of distal body chipped, the possibility of dropping into human body could not be denied.Moreover, based on the technical report, ""hr-rpt-0974(distal end)"" and/or the risk analysis results, it was evaluated to submit mdr.

• 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 07645 ; 8004315800
• MDR Report Key: 16687970
• MDR Text Key: 312796471
• Report Number: 9610877-2023-53025
• Device Sequence Number: 1
• Product Code: EOQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EB-1970K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2023
• 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