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

Model Number VNL-1570STK

Device Problem Device Reprocessing Problem (1091)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical was made aware of an event that occurred after reprocessing in the united states.The reported complaint that there is potential endoscope contamination.After reprocessing, white residue was observed within the channel while examining the pentax endoscope with a borescope, involving the pentax medical video naso-pharyngo-laryngoscope(vnl) , model vnl-1570stk., serial number (b)(4).No patient involvement was reported.The endoscope was received by pentax medical for evaluation on 23-sep-2020.The endoscope was inspected by pentax medical service under service order (b)(4) and the technician documented the following inspection findings on 28-sep-2020: operation channel- primary mild resistance, passed dry leak test, passed wet leak test, hole in # 4 remote control button cover, fluid invasion not observed in pve connector, fluid invasion not observed in control body.The endoscope underwent repairs including the following components: r.C.Button (4) pb-free, o-rings and seals.Pentax medical, model vnl-1570stk., serial number (b)(4) has been routinely serviced at a pentax facility since the device was put into service on (b)(6) 2014.The endoscope was delivered to the customer on (b)(6) 2020 under delivery order (b)(4).

Manufacturer Narrative

Evaluation summary: following reprocessing at the facility, culture testing revealed a white residue containing stenotrophomonas maltophilia, and gram negative rods.The product was then sent to pentax with the following findings: it's been found.Insertion tube buckle under root brace, wet leak test passed, long umbilical cable bump, short umbilical cable bump, insertion tube wear, dry leak test passed, #4 remote control button intermittent function, insertion tube at stage 1 cut, no visible liquid intrusion on pve connector, no visible liquid ingress on control body, operation channel - minor scratch inside, #4 remote control button cover punctured.It is assumed that the above observations were combined and the reprocessing process could not be carried out satisfactorily.The dhr stated that it passed all required inspections and was released.

• Brand Name: PENTAX
• Type of Device: 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: 10693216
• MDR Text Key: 255037269
• Report Number: 9610877-2020-00170
• Device Sequence Number: 1
• Product Code: EQN
• UDI-Device Identifier: 04961333233809
• UDI-Public: 04961333233809
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: VNL-1570STK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1