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

Model Number EG29-I10C

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

This model is not distributed in the united states, therefore 510k is not applicable.We do have similar model eg29-i10c-us available in the united states with a 510k number k190805.(b)(4).This complaint is being processed in accordance with dpa-qip-mdr decision backlog management plan.If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Pentax medical was made aware of a complaint which occurred in the emea region reporting "the a/w[air water] connector at the lg plug is loosened and leaky" involving pentax medical video gastroscope model eg29-i10c, serial number (b)(4).The event was reported to occur in the operating room, before use.There was no report of death, serious injury or other significant/important medical event.The a/w connector must be fastened and the endoscope must be checked because of a potential fluid damage as part of the service request.This event is fda reportable due to the lack of information to justify that this event would not cause or contribute to a serious injury or other adverse event.

• 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
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12354295
• MDR Text Key: 267717816
• Report Number: 9610877-2021-00742
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1