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

Model Number ED34-I10T2

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

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

Event Date 06/07/2021

Event Type  malfunction  

Manufacturer Narrative

This device is classified as import for export, therefore 510k is not applicable.Modeled34-i10t2-us is available in the usa with a 510k number k192245.The device was returned, but it's still under investigation,so the results of the investigation will be provided in a supplemental report.

Event Description

The l/r angulation wheel fell off.This event occurred at the time of before use.There was no report of patient harm.

Manufacturer Narrative

Evaluation summary: we checked the returned unit and confirmed that the improper adjustment on r/l lock knob and the u/d lock lever, the deflector wire hard to move, the ccd module pixels defect, and the lg prong top assy loosen.Based on the result, we concluded that it was caused due to the improper adjustment; however, other failures are not related to the alleged complaint.Correction information: g6: 30-day follow-up #1.H3: device evaluated by manufacturer.Additional information: h2: correction, additional information, device evaluation.H6: coding added based on the investigation result: medical device problem code, component code, type of investigation, investigation findings, investigation conclusions.This report is being filed as part of the pentax backlog management plan.

• Brand Name: PENTAX
• Type of Device: VIDEO DUODENOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12119478
• MDR Text Key: 260007892
• Report Number: 9610877-2021-10031
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04961333247455
• UDI-Public: 04961333247455
• Combination Product (y/n): N
• 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: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ED34-I10T2
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1