MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE

Model Number	EG-3890TLK
Medical Device Problem Codes	Partial Blockage (1065); Device Fell (4014)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to pentax for further evaluation on service order (b)(4) where the user narrative was not confirmed.The inspection findings are as follows: passed dry leak test, air/ water nozzle glue missing, bending rubber glue cracking at insertion tube side, customer complaint not duplicated, distal body chipped, passed wet leak test the device was repaired where all defects found was remediated and return to the user on delivery (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 an event which occurred in the pai region involving pentax video scope eg-3890tlk.In the event reported, the user states the primary channel is blocked.The timing of the event is unknown.There was no adverse event reported with this complaint.No other information provided with this complaint.
Additional Manufacturer Narrative
Evaluation summary: customer reported primary channel blocked.The customer stated unknown object in channel.However, there was no repair data that could determine the cause.We checked the returned unit and confirmed that the air/water nozzle missing.Based on the result, we concluded that it was caused due to the physical damage applied on the air/water nozzle.Correction information: g6: follow up #1, h2: type of follow up.H6: coding changed based on the investigation result.Additional information: h4: device manufacture date.

• Brand Name: PENTAX
• Common Device Name: VIDEO GASTROSCOPE
• 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: 12951160
• Report Number: 9610877-2021-01681
• Device Sequence Number: 20034471
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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-3890TLK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 10/24/2022
• Date Device Manufactured: 12/08/2017
• 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