MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE 2.8C 9.8T 1050L

Model Number	EG-2990K
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The time of event is unknown.There was no report of patient harm.Air/water nozzle missing.
Additional Manufacturer Narrative
The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the air nozzle missing.Based on the result, we concluded that it was caused due to the physical damage applied on the air nozzle.In addition, our technician confirmed that the water nozzle missing; however, this defect is not the main cause, and/or irrelevant to the alleged complaint.As a result of confirming the detail as gfe, we got a ""no"" answer to the question of whether the nozzle was fallen into the human body or not.Therefore, based on the technical report""hr-rpt-0585(nozzle)"" and/or the risk analysis results, it was evaluated not to submit mdr.
Additional Manufacturer Narrative
Correction information.B4: date of this report.G6: follow up #1.H2:if follow-up, what type? there were typos in some of the investigation results, which have been corrected.The product was returned to pentax medical for repair.Our technician checked the returned unit and confirmed that the air nozzle missing.Based on the result, we concluded that it was caused due to the physical damage applied on the air nozzle.In addition, our technician confirmed that the water nozzle missing; however, this defect is not the main cause, and/or irrelevant to the alleged complaint.In terms of the nozzle missing, the possibility of dropping into human body could not be denied.Therefore, based on the technical report ""hr-rpt-0585(nozzle)"" and/or the risk analysis results, it was evaluated to submit mdr.

• Brand Name: PENTAX
• Common Device Name: VIDEO GASTROSCOPE 2.8C 9.8T 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 ; 8004315800
• MDR Report Key: 18490563
• Report Number: 9610877-2024-50105
• Device Sequence Number: 20579414
• Product Code: FDS
• UDI-Device Identifier: 04961333129508
• UDI-Public: 04961333129508
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/09/2024

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-2990K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 02/09/2024
• 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