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

Model Number EG29-I10

Device Problems Partial Blockage (1065); Break (1069)

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

Event Date 12/14/2021

Event Type  malfunction  

Event Description

Pentax medical was made aware of an event which occurred in the pai region involving pentax video scope eg29-i10.In the event reported, the service technician found a stuck accessory in the biopsy channel during inspection.The event timing is in the service facility, during inspection.There was no adverse event reported with this complaint.No other information provided with this complaint.

Manufacturer Narrative

The device was received at pentax medical on service order (b)(4) for further evaluation.The device was inspected where the user narrative was confirmed.The inspection findings are as follows: accessory stuck in primary operation channel, passed dry leak test, air/ water nozzle glue missing, distal body chipped, passed wet leak test, insertion tube bump at stage 1, air/ water socket cylinder o-ring chipped, suction tube twisted/kink, customer complaint confirmed.The device was repaired where all defects found was remediated and returned to the user on delivery note (b)(4).If additional information becomes available, a supplemental report will be filed with the new information.

Manufacturer Narrative

Correction information: h6: coding changed, based on the investigation result.Evaluation summary: this is an event, in which a check valve attached to a component of an endoscope clogs.The aspiration line.The cause is thought to be, that the check valve that got into the washing machine, during the washing process, clogs the pipe with the water flow.

• 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
• 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: 13231735
• MDR Text Key: 290295637
• Report Number: 9610877-2022-00053
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333211692
• UDI-Public: 04961333211692
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1