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

Model Number	VNL8-J10
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported a complaint to customer service on 25-jun-2021 for a "no video image" that occurred in the united states involving pentax medical video naso pharyngo laryngoscope, model vnl8-j10, serial number (b)(4).The user facility responded to good faith effort(gfe) emails from 28-jun-2021 and 30-jun-2021 via email on 06-jul-2021 however the attachment only includes a line stating that "the scope has been checked on two different processors and only black screen comes up, no other image".No additional information was provided.No additional answers to our questions were answered.The customer owned endoscope was received by pentax medical for evaluation on 07-jul-2021.The colonoscope was inspected by pentax medical service under service order (b)(4) and the technician identified "image blackout" as well documenting the following inspection findings on 13-jul-2021: leak at # 3 remote control button cover, up/ down control knob/ lever plastic cover @ pivot separated, some functions cannot be checked unit compromised by fluid, trim cap missing, insertion tube severe crush at stage 1, insertion tube severe crush at stage 3, leak at # 2 remote control button cover, # 4 remote control button cover cracked, # 1 remote control button cover cracked, # 2 remote control button cover cracked, # 3 remote control button cover cracked, leak at # 4 remote control button cover, leak at # 1 remote control button cover.The device underwent repairs for the slice in the channel and fluid invasion including the following components: o-rings and seals, distal end w/ccd module ntsc, distal attaching pin, segment steel braid, bending rubber, insertion flex tube w/segment, angle lever assy, angle lever trim cap, remote control button(2), remote control button(3), remote control button(4), remote control button(1).Model vnl8-j10, serial number (b)(4), serial number (b)(4), has been routinely serviced at a pentax facility since the device was put into service on 03-jan-2019.The endoscope is awaiting repair or approval by final qc as of 22-jul-2021.
Additional Manufacturer Narrative
(b)(4).If additional information becomes available, a supplemental report will be filed with the new information.
Additional Manufacturer Narrative
Correction information: g6: follow up #1, h2: if follow-up, what type? h6: coding changed based on the investigation (health effect - clinical code, health effect - impact code).Additional information: h4: device manufacture date.

• Brand Name: PENTAX
• Common Device Name: VIDEO NASO PHARYNGO LARYNGOSCOPE
• 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: 12214279
• Report Number: 9610877-2021-00251
• Device Sequence Number: 18272039
• Product Code: EOB
• UDI-Device Identifier: 04961333225354
• UDI-Public: 04961333225354
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K172156
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2022

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: VNL8-J10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 07/22/2021
• Supplement Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2018
• 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