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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.
Event or Problem Description
Pentax medical was made aware of a complaint that occurred in the united states that failed the wet and dry leak testing out of the box, involving pentax medical video gastroscope model eg-3890tk, serial number (b)(4).The customer is sending the device back to pentax for evaluation.The user has to clean loaners out of the box before they can use them on a patient.The gastroscope was removed from circulation immediately after the event occurred and the facility follows instructions for use.The loaner endocscope was returned with the customer owned endoscope for evaluation on 30-aug-2021 under service order (b)(4).The loaner endoscope is currently awaiting inspection as of 22-sep-2021.Model eg-3890tk, serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service.The investigation is in-process.
Additional Manufacturer Narrative
Evaluation summary: there was a leak in the delivered scope, and the leak location could not be identified from the information obtained.The cause of the leak is unknown.Correction information: g6: follow up #1; h2: type of follow up; h3: device evaluated; h6: coding changed based on the investigation result.Additional information: d4: udi; h4: device manufacture date.

• 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: 12513193
• Report Number: 9610877-2021-00532
• Device Sequence Number: 4053886
• Product Code: FDS
• UDI-Device Identifier: 04961333227099
• UDI-Public: 04961333152827
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• 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: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/22/2021
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2013
• 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