MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; FIBEROPTICCYSTOSCOPE 2.1C 4.9TP 400L ROP

Model Number FCY-15RBS

Device Problem Break (1069)

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

Event Date 11/24/2022

Event Type  malfunction  

Event Description

The time of event is unknown.There was no report of patient harm.Fiber image failure(broken).

Manufacturer Narrative

This device is classified as import for export, therefore 510k is not applicable.Model fb-15v is available in the usa with a 510k number k951199.We checked the returned unit and confirmed that the image guide fiber bundle (cfb) was broken.Based on the result, we concluded that it was caused due to the excessive force applied on the image guide fiber bundle (cfb).In addition, we confirmed that the insertion flexible tube (ift) buckled, and the control body worn out; however, they are 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.

• Brand Name: PENTAX
• Type of Device: FIBEROPTICCYSTOSCOPE 2.1C 4.9TP 400L ROP
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645
• MDR Report Key: 15957430
• MDR Text Key: 307993556
• Report Number: 9610877-2022-60957
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04961333228058
• UDI-Public: 04961333083664
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/12/2022

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: FCY-15RBS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2022
• Initial Date FDA Received: 12/12/2022
• 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