MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE

Model Number	VLS-1070STK
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Pentax medical was made aware of an event which occurred in the pai region involving pentax video scope vls-1070stk.In the event reported, the user states that there no video image.The timing of the event is unknown.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
This device is classified as exempt, therefore 510k is not applicable.The device was returned to pentax for further evaluation on service order (b)(4) and the inspection findings confirmed the user narrative.Inspection findings are as follows: fluid invasion in pve connector, insertion tube buckles at stage 1, image blackout, long umbilical cable buckle at control body side, pve connector housing corroded, pve electrical connector frame has severe corrossion, insertion tube buckles at end of root brace, customer complaint confirmed, hole in # 4 remote control button cover, shield cover corroded, umbilical cable, short fluid invasion, some functions cannot be checked unit compromised by fluid the device is in the process of being repair where all defects found will be remediated and returned to the user upon completion.On (b)(6) 2021, a device history record (dhr) review for model vls-1070stk, serial number (b)(4) was performed and the dhr review confirmed the endoscope was manufactured on 20nov2017 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: customer reported no video image.The customer stated the camera is not working - black screen.Therefore, we checked the returned unit and confirmed that the ccd module failure.Based on the result, we concluded that it was caused due to the excessive force applied on the ccd module.Correction information: g6: follow up #1, h2: type of follow up, h6: coding changed based on the investigation result.

• Brand Name: PENTAX
• Common Device Name: VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE
• 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: 13010681
• Report Number: 9610877-2021-01852
• Device Sequence Number: 19264146
• Product Code: EOB
• UDI-Device Identifier: 04961333240371
• UDI-Public: 04961333240371
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H10
• 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: VLS-1070STK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 10/24/2022
• Date Device Manufactured: 11/20/2017
• 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