MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; NASOPHARYNGOSCOPE

Model Number VNL-1570STK

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax of america initiated field correction 2017-008-c which included inspection of the suction arm on affected models pursuant to predefined inspection criteria (qs-397).The objective of the inspection was to locate part c255-ab171 (suction arm) and verify it is not loose.If part c255-ab171 (suction arm) is found loose, the device was considered to fail the inspection criteria.The customer owned device was previously returned to pentax medical from the customer on 13-sep-2019 for poor illumination of video image.The video naso-pharyngo-laryngoscope was inspected by pentax medical service on (b)(6)2019 and the following inspection findings were documented: suction arm loose, insertion tube buckles at end of root brace, fluid invasion in control body, distal body chip at channel opening at thinnest part, fluid invasion in segment section, image blackout, failed dry leak test, up/ down control knob/ lever cracked, long umbilical cable buckle at junction, failed wet leak test, leak at biopsy channel (large/ primary) distal side, umbilical cable for pve connector buckled, fluid invasion to insertion tube, fluid damage to light carrying bundle, hole in # 3 remote control button cover, control body corroded, primary operation channel resistance, insertion tube severe crush at stage 1, insertion tube severe crush at stage 2.Inspection of the suction arm was also performed on (b)(6) 2019 and the device failed the inspection criteria.The video naso-pharyngo-laryngoscope was repaired including the following components: parts replaced: video naso pharyngo laryngoscope, insertion flex tube w/seg pb-free, bending rubber, light guide cable long, light guide cable for connector, angle lever assy, o-rings and seals, distal end, ,w/ccd-m pb-free/ntsc, insertion/s-nipple attaching screw, suction connection tube.The video naso-pharyngo-laryngoscope is pending approval by final qc as of 10-oct-2019.

• Brand Name: PENTAX
• Type of Device: NASOPHARYNGOSCOPE
• 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: 9175215
• MDR Text Key: 196130513
• Report Number: 9610877-2019-01481
• Device Sequence Number: 1
• Product Code: EOB
• 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: company representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: VNL-1570STK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Manufacturer Received: 09/16/2019
• Initial Date FDA Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: NOT ISSUED YET
• Patient Sequence Number: 1