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

Model Number FCY-15RBS

Device Problems Fracture (1260); Loose or Intermittent Connection (1371)

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

Event Date 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: it was caused due to an excessive force applied on the instrument channel inlet.In addition, we confirmed that the forward body cover break; however, it is not related to the alleged complaint.This device is classified as import for export, therefore 510k is not applicable.This report is being filed as part of the pentax backlog management plan.

Event Description

(b)(6) 2021 i noticed that the forceps opening was loose during cleaning the day before and contacted me.Replaced with a substitute because the forceps opening is loose as before.Repair custody.Regarding the confirmation of the installation of the t-shaped tube, it is said that it has already been known that the installation of the t-shaped tube was explained at the previous visit.It is said that other manufacturers can not know the same thing.Borrow the t-shaped tube used this time for verification.This event occurred at the time of reprocessing.There was no report of patient harm.

• 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 ; 8004315880
• MDR Report Key: 12200847
• MDR Text Key: 263397191
• Report Number: 9610877-2021-10284
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04961333228058
• UDI-Public: 04961333228058
• 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: 07/21/2021

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: FCY-15RBS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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