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

Model Number FNL-10PR3

Device Problem Flare or Flash (2942)

Patient Problem No Patient Involvement (2645)

Event Date 08/20/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical became aware of a report on 06mar2020 stating, "due to that the scope would produce the high temperature after using a long time, there was no effective isolation, so it caused the cloth liner/placemat was fired.The operating room had heavy smell of the burnt and it would have the risk of the fire.", involving pentax medical fiber naso pharyngo laryngoscope, model fnl-7rp3/serial number (b)(4).Information obtained from report number: (b)(4), the local adverse event report form created on 25oct2019, that was submitted to the (b)(4) food and drug administration (cfda).

Event Description

Pentax medical became aware of a report on 06mar2020 stating, "due to that the scope would produce the high temperature after using a long time, there was no effective isolation, so it caused the cloth liner/placemat was fired.The operating room had heavy smell of the burnt and it would have the risk of the fire.", involving pentax medical fiber naso pharyngo laryngoscope, model fnl-10pr3/serial number (b)(4).Information obtained from report number: (b)(4), the local adverse event report form created on 25oct2019, that was submitted to the china food and drug administration (cfda).

• 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
• MDR Report Key: 9919151
• MDR Text Key: 186283781
• Report Number: 9610877-2020-00070
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04961333070909
• UDI-Public: 04961333070909
• Combination Product (y/n): N
• PMA/PMN Number: K951196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FNL-10PR3
• Device Lot Number: G119909
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1