MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBEROPTICINTUBATIONSCOPE 2.6C 5.1TP ROP

Model Number FI-16RBS

Device Problem Poor Quality Image (1408)

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

Event Date 12/31/2020

Event Type  malfunction  

Manufacturer Narrative

This device is not available for sale in the united states, therefore 510k is not applicable.If additional information becomes available, a supplemental report will be filed with the new information.This complaint is being processed in accordance with dpa-qip-mdr decision backlog management plan.

Event Description

Pentax medical was made aware of an event which occurred in the asia pacific region involving pentax fiber intubation scope fi-16rbs.In the event reported the user stated that on dec.22, the user prepared the inspection for the patient and found the vague image at 3 o'clock.The nurse did the leakage test for the scope and found the scope had leakage.Then the nurse stopped in using scope and contacted the engineer.This defect was detected in the operating room before use.There is no adverse event reported with this complaint.No additional information was provided.

• Brand Name: PENTAX
• Type of Device: FIBEROPTICINTUBATIONSCOPE 2.6C 5.1TP ROP
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12351878
• MDR Text Key: 283147475
• Report Number: 9610877-2021-00672
• Device Sequence Number: 1
• Product Code: CAL
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial
• Report Date: 08/21/2021

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-16RBS
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 08/21/2021
• 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