MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE 3.8C 2.8C 12.8T FWJ

Model Number	EG-3890TK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Pentax medical was made aware of an event which occurred in the (b)(6) involving pentax endoscope model eg-3890tk.In the event reported, the user stated the device is broken (no angulation).The event timing is in the procedure room during use.There was no adverse event reported with this complaint.No other information provided with this complaint.This event meets the requirement for fda reportability; therefore, submission of a report does not constitute an admission that medical personnel, user facility, importer, manufacturer, or product caused or contributed to the event.
Additional Manufacturer Narrative
The device was returned to pentax for further evaluation on service order 3137801 where the user narrative was confirmed.The device is in the process of being repair where all defects found will be remediated and returned to the user upon completion.On 07-jan-2022, a device history record (dhr) review for model eg-3890tk, serial number (b)(4) was performed and the dhr review confirmed the endoscope was manufactured on 07dec17 under normal conditions, passed all required inspections, and was released accordingly.The dates of approval for shipment and actual date shipped were confirmed.If additional information becomes available, a supplemental report will be filed with the new information.
Additional Manufacturer Narrative
Evaluation summary: it were unable to determine the cause of the complaint from the repair information.There is a possibility that the angle wire is broken as a cause of angulation to not perform.Correction information: g6: follow up #1.H2: type of follow up.H6: coding changed based on the investigation result.Additional information h3: device evaluated.

• Brand Name: PENTAX
• Common Device Name: VIDEO GASTROSCOPE 3.8C 2.8C 12.8T FWJ
• 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 (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 13385619
• Report Number: 9610877-2022-00147
• Device Sequence Number: 4678174
• Product Code: FDS
• UDI-Device Identifier: 04961333152827
• UDI-Public: 04961333152827
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2022

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
• Operator of Device: Health Professional
• Device Model Number: EG-3890TK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2017
• 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