MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE

Model Number EC38-I10CF2

Device Problems Fluid/Blood Leak (1250); Poor Quality Image (1408); Decrease in Pressure (1490); Pressure Problem (3012)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/02/2021

Event Type  malfunction  

Manufacturer Narrative

This device is not distributed in the usa, therefore there is no 510k available.(b)(4).We will continue to investigate this situation and if necessary, file a supplemental report.This complaint is being processed in accordance with dpa-qip-mdr decision backlog management plan.

Event Description

Pentax medical was made aware of an event that occurred in the emea region.The event occurred in the reprocessing room.The user reported air/water connector at the light guide plug leaky involving pentax model ec38-i10f2/serial (b)(4).The endoscope was returned to pentax service facility for further evaluation where the user narrative was confirmed along with additional findings.Additional findings: connecting screws loosen, moisture inside the lg plug, image disturbance.

Manufacturer Narrative

Evaluation summary: we checked the returned unit and confirmed the air/water nozzle clogged, the u/d and r/l pulley wires streching, the ccd driver pcb corrosion, the lg cable connector assy corrosion, and the lg cable connector housing a-c0002 leak.Based on the result, we concluded that it was caused due to the lg cable connector housing a-c0002 leak; however, other failures are not related to the alleged complaint.Correction information: g6: follow up #1.H6: coding changed based on the investigation result: medical device problem code, component code, investigation findings, and investigation conclusions.B5: there was no report of patient harm.H2: follow up type.H6: coding added based on the investigation result: health effect - clinical code.This report is being filed as part of the pentax backlog management plan.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12111727
• MDR Text Key: 262248801
• Report Number: 9610877-2021-00160
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC38-I10CF2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1