MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C

Model Number	EG-3670URK
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
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 ccd module with drive pcb blackout.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module with drive pcb.In addition, our technician confirmed that the insertion flexible tube fluid damage, the segment fluid damage, the control body fluid damage, the ground wire fluid damage, the lcb (light carrying bundle) fluid damage, the us connector cable (long) fluid damage, the us connector/junction cable (short) fluid damage, the ultrasound connector body fluid damage, the lg connector corroded, the operation channel (primary) leak, the us probe noise, the us probe eus image no scanline, and the us probe eus image no scanline; however, these defects are not the main cause, and/or irrelevant to the alleged complaint.Based on the technical report ""hr-rpt-0586(image failure)"" 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.Video image failure(blackout ).

• Brand Name: PENTAX
• Common Device Name: RADIAL ULTRASOUND VIDEO GASTROSCOPE 2.4C
• 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: 18490440
• Report Number: 9610877-2024-50110
• Device Sequence Number: 17060154
• Product Code: ODG
• UDI-Device Identifier: 04961333123360
• UDI-Public: 04961333123360
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K182004
• 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
• Report Date (Section B): 01/11/2024

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-3670URK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 01/11/2024
• 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