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

International medical device regulators forum (imdrf) adverse event reporting (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: insertion tube buckles under the root brace, passed wet leak test, long umbilical cable bump, short umbilical cable bump, insertion tube abrasion, passed dry leak test, #4 remote control button intermittent function, cut on insertion tube at stage 1, fluid invasion not observed in pve connector, fluid invasion not observed in control body, operation channel- primary mild scratch inside, hole in # 4 remote control button cover.The endoscope underwent repairs including the following components: o-rings and seals, r.C.Button (4) pb-free, suction connection tube, insertion/s-nipple attaching screw, o-ring(1.25x3.5), o-ring(1.2x3.5).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) 2017.The endoscope was delivered to the customer on 06-oct-2020 under delivery order (b)(4).

Manufacturer Narrative

Evaluation summary: after reprocessing at the facility, a culture test was performed, which revealed a white residue with stenotrophomonas maltophilia, and gram negative rods.The product was then sent to pentax, where the following findings were made insertion tube buckles under root brace, wet leak test passed, long umbilical cable bumps, short umbilical cable bumps, insertion tube wear, dry leak test passed, #4 remote control button intermittent function, insertion tube disconnected at stage 1, no liquid ingress at pve connector, no liquid ingress at control body no liquid ingress seen, no liquid ingress seen in control body, operation channel - minor scratches on inside, hole in cover of #4 remote control button.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.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
• 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: 10692176
• MDR Text Key: 211952766
• Report Number: 9610877-2020-00169
• 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: 06/09/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1