MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE 2.0C 5.4T 1050L

Model Number EG-1690K

Device Problem Unintended Movement (3026)

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

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

We checked the returned unit and confirmed that the angulation-up stuck in j position.Based on the result, we concluded that it was caused due to the excessive force applied on the angulation-up.In addition, we confirmed that the insertion flexible tube (ift) buckled, the light guide cable buckled, the insertion flexible tube (ift) bump, the air/water socket chipped/cut o-ring, the angulation-down stuck in l position, the angulation-left stuck in l position, and the angulation-right stuck in l position; however, they are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0587(angle)"" and/or the risk analysis results, it was evaluated to submit mdr.

Event Description

The time of event is unknown.There was no report of patient harm.Angulation stuck.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE 2.0C 5.4T 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
• MDR Report Key: 15256499
• MDR Text Key: 305179591
• Report Number: 9610877-2022-56781
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333146192
• UDI-Public: 04961333146192
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-1690K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1