MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBEROPTIC INTUBATION SCOPE

Model Number FI-10BS

Device Problem Poor Quality Image (1408)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

Pentax medical became aware of a report for an event which occurred in (b)(6)stating, "optic failure, unclear focus " involving pentax model fi-10bs/serial (b)(4).No further information was provided at the time of the report.The device was returned to pentax medical potsdam service workshop where the following was confirmed: unclear focus, cfb misadjusted at ocular side.The cfb will be adjusted.

Manufacturer Narrative

Pentax model fi-10bs is not distributed in usa, therefore 510k is not applicable.If additional information becomes available, a supplemental report will be filed with the new information.

• Brand Name: PENTAX
• Type of Device: FIBEROPTIC INTUBATION SCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12289199
• MDR Text Key: 282822859
• Report Number: 9610877-2021-00368
• Device Sequence Number: 1
• Product Code: CAL
• Combination Product (y/n): N
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 08/06/2021

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: FI-10BS
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 08/06/2021
• 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