MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBER NASO PHARYNGO LARYNGOSCOPE

Model Number FNL-7RP3

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Device manufacture date unknown.Evaluation summary: it was caused due to the improper reprocessing at the hospital.It is not the product failure.This report is being filed as part of the pentax backlog management plan.

Event Description

Not known for the exact date, we just know the year the complaint was sent in to manufacturer.This event occurred at the time of reprocessing.Potential endoscope contamination.

• Brand Name: PENTAX
• Type of Device: FIBER NASO PHARYNGO LARYNGOSCOPE
• 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: 12243728
• MDR Text Key: 264087450
• Report Number: 9610877-2021-10370
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04961333224234
• UDI-Public: 04961333224234
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951196
• 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: 07/29/2021

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: FNL-7RP3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1