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

Model Number	EG-1690K
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the angle wire rupture.Based on the result, we concluded that it was caused due to the excessive force applied on the angle wire.In addition, our technician confirmed that the insertion flexible tube bump, the angulation down angulation zero degrees, the angulation up angulation zero degrees, and the r/l knob white marking faded/missing; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.As a result of confirming the detail as gfe, no response was obtained, so we cannot deny the possibility of the angle stuck.Therefore, based on the technical report ""hr-rpt-0587(angle)"" and/or the risk analysis results, it was evaluated to submit mdr.
Event or Problem Description
The time of event is unknown.There was no report of patient harm.Angle wire cut.
Additional Manufacturer Narrative
G6: follow up #1.Additional information as a result of investigation in pentax medical america on 16-may-2023, it was found that the angulation was not stuck in j-position.Based on the result, we have re-evaluated the decision tree and determined that this event is not reportable.Pentax medical has not received any further information for this event and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Common Device Name: VIDEO GASTROSCOPE 2.0C 5.4T 1050L
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishisima-shi, tokyo 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 16936741
• Report Number: 9610877-2023-54351
• Device Sequence Number: 20676510
• Product Code: FDS
• UDI-Device Identifier: 04961333146192
• UDI-Public: 04961333146192
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131902
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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
• Operator of Device: Health Professional
• Device Model Number: EG-1690K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown