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

Model Number VNL8-J10

Device Problem Fracture (1260)

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

Event Date 01/06/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

When transporting the scope, he noticed a rattling noise from the light guide branch this event occurred at the time of before use.There was no report of patient harm.

Manufacturer Narrative

Evaluation summary: we checked the returned unit and confirmed that the "impurities" or "filth" is attached on the scope or camera, we concluded that it was caused due to the insufficient reprocessing at the facility.In addition, we confirmed that the core disconnected; however, it is not the main cause, and/or irrelevant to the alleged complaint.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 ENT SCOPE
• 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: 13233384
• MDR Text Key: 287922440
• Report Number: 9610877-2022-00119
• Device Sequence Number: 1
• Product Code: EOB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172156
• 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: 03/16/2022

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: VNL8-J10
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 01/06/2022
• Supplement Dates FDA Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1