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

Model Number EG29-I10C

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: it is assumed that the screws were loosened by repeatedly attaching and detaching the adapter to the aw connector.A service manual for changing the screw lock application position was issued on 11jun2021, and training was conducted at the service center.This device is not marketed in us, therefore 510k is not applicable.Model eg29-i10c-us is available in the usa with a 510k number k190805.

Event Description

A/w connector at the lg plug loosened.This event occurred at the time of during inspection.There was no report of patient harm.

• Brand Name: PENTAX
• Type of Device: IMAGINA 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: 12701576
• MDR Text Key: 283965978
• Report Number: 9610877-2021-01282
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333237586
• UDI-Public: 04961333237586
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG29-I10C
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1