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

Model Number FCY-15RBS

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

Pentax medical will be providing supplemental information after follow up on the event.The device involved in this event is not distributed in the usa, therefore 510k is not applicable.

Event Description

Pentax medical was made aware of a report for an event which occurred in (b)(6) stating, "loose mouthpiece on the forceps opening", involving pentax model fcy-15rbs/serial (b)(4).The malfunction was observed in the reprocessing room after the procedure.There was no report of patient harm.No other information was provided at the time of the report.The device has not been returned to pentax medical for evaluation.

Manufacturer Narrative

Evaluation summary: we checked the returned unit and confirmed that the fwd body cover with eog valve broken, the insertion flex tube w/seg pb-free crushed, and the angle lever assy cracked.Based on the result, we concluded that it was caused due to the fwd body cover with eog valve broken; however, other failures are not related to the alleged complaint.Correction information: follow up #1.Additional information: device available for evaluation, follow up type, device evaluation, coding added based on the investigation result: component code, type of investigation, investigation findings, and investigation conclusions.This report is being filed as part of the pentax backlog management plan.

• 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
• MDR Report Key: 12111733
• MDR Text Key: 281670070
• Report Number: 9610877-2021-00164
• Device Sequence Number: 1
• Product Code: FAJ
• 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,Followup
• Report Date: 08/05/2021

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
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 06/02/2021
• Supplement Dates FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1