MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO UPPER GI SCOPE

Model Number EG29-I10

Device Problem Mechanical Problem (1384)

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

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

The reported customer complaint of leaking at the bending rubber could not be confirmed without the return of the device nor an exact cause determined.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 apac region involving pentax model eg29-i10 video gastroscope.The information provided indicated that there was a leak in the bending rubber.The failure was discovered in the reprocessing room during reprocessing.

• Brand Name: PENTAX
• Type of Device: VIDEO UPPER GI SCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• MDR Report Key: 12355579
• MDR Text Key: 280962254
• Report Number: 9610877-2021-00682
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial
• Report Date: 08/22/2021

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: EG29-I10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1