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

Model Number	FCY-15RBS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2023
Type of Reportable Event	Malfunction
Additional 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.The product was returned to pentax medical for repair.We checked the returned unit and confirmed that the ocular fluid damage.Based on the result, we concluded that it was caused due to the fluid damage from the ocular.In addition, we confirmed that the u/d knob broken, the light guide fiber bundle (lcb) broken, the segment compressed, the insertion flexible tube (ift) buckled, and the image guide fiber bundle (cfb) dirty; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report and/or the risk analysis results, it was evaluated to submit mdr.
Event or Problem Description
The time of event is unknown.There was no report of patient harm.Fiber image failure(fluid damage).

• Brand Name: PENTAX
• Common Device Name: FIBEROPTICCYSTOSCOPE 2.1C 4.9TP 400L 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
• MDR Report Key: 16543278
• Report Number: 9610877-2023-52206
• Device Sequence Number: 6452991
• Product Code: FAJ
• UDI-Device Identifier: 04961333083664
• UDI-Public: 04961333083664
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: FCY-15RBS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown