MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBEROPTICINTUBATIONSCOPE

Model Number FI-16RBS

Device Problem Poor Quality Image (1408)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

Continued: pentax model fi-16rbs is classified as exempt.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of a report that occurred in the apac region stating "during use, the lens was foggy.Lavage fluid was poor suction" involving pentax model fi-16rbs/serial unknown.No further information was provided at the time of the report.This event meets the requirements for fda reportability; however submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.

• Brand Name: PENTAX
• Type of Device: FIBEROPTICINTUBATIONSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12251733
• MDR Text Key: 264325267
• Report Number: 9610877-2021-00426
• 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: 07/30/2021

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
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/30/2021
• 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