MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE 2.4C 8.0T 1050L

Model Number EG-2490K

Device Problems Partial Blockage (1065); Collapse (1099); Mechanical Problem (1384); Failure to Disconnect (2541)

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

Event Date 10/04/2022

Event Type  malfunction  

Manufacturer Narrative

If additional information becomes available, a supplemental report will be filed with the new information.

Event Description

Accessory/object stuck in the operation channel.This event occurred at the time of during inspection.There was no report of patient harm.

Manufacturer Narrative

Correction information: g6: follow up #1, h2:if follow-up, what type? h3:device evaluated by manufacture, h6: coding changed based on the investigation result.Additional information: h4:device manufacture date.Evaluation summary: in this case, according to the reported incident and the attached photo, the cleaning brush was stuck in the pipe due to the use of an incompatible cleaning brush.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE 2.4C 8.0T 1050L
• 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 ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 15664786
• MDR Text Key: 302492896
• Report Number: 9610877-2022-00581
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/26/2022

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: EG-2490K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 10/04/2022
• Supplement Dates FDA Received: 12/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1