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

Model Number FI-16RBS

Device Problem Overcorrection (3006)

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

Event Date 08/02/2023

Event Type  malfunction  

Manufacturer Narrative

This device is not distributed in us so that 510k# is blank.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the cfb (coherent fiber bundle) as defective.Based on the result, we concluded that it was caused due to the improper adjustment on the cfb (coherent fiber bundle).In addition, our technician confirmed that the insertion flexible tube buckled; however, this defect is not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0586(image failure)"" and/or the risk analysis results, it was evaluated to submit mdr.

Event Description

The time of event is not during procedure.There was no report of patient harm.Fiber image failure(observation position shift).

• Brand Name: PENTAX
• Type of Device: FIBEROPTICINTUBATIONSCOPE 2.6C 5.1TP ROP
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 17609039
• MDR Text Key: 321812793
• Report Number: 9610877-2023-57954
• Device Sequence Number: 1
• Product Code: CAL
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2023

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Initial Date Manufacturer Received: 08/02/2023
• Initial Date FDA Received: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1