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

Model Number VNL-1570STK

Device Problems Device Reprocessing Problem (1091); Coagulation in Device or Device Ingredient (1096)

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

The reported complaint was called into pentax medical customer service on 12-dec-2019, and reported biofilm and corrosion found during pre-inspectional check of the endoscope and was documented as "potential endoscope contamination" involving a pentax medical video naso-pharyngo-laryngoscope(npl).No serious injury or death of a patient or user, or delay in the procedure which would require medical intervention was reported.The customer owned video naso-pharyngo-laryngoscope(npl) was received by pentax medical for evaluation on 19-dec-2019.The npl was inspected by pentax medical service on 27-dec-2019, and the following inspection findings were documented: segment crushed, passed dry leak test, short umbilical cable buckle at umbilical connector side, passed wet leak test, pve electrical connector frame mild corrosion.Pentax medical video naso-pharyngo-laryngoscope(npl), vnl-1570stk, serial number (b)(4), has been routinely serviced at a pentax facility since the device was put into service on 30-apr-2009.The duodenoscope underwent repairs including the following components: insertion flex tube w/seg pb-free, distal end assy with tube, bending rubber, biopsy inlet t-piece, biopsy inlet barrel, o-rings and seals, insertion/s-nipple attaching screw, o-ring(1.25x3.5), suction connection tube, o-ring(1.2x3.5).The naso-pharyngo-laryngoscope is pending repair completion, resampling and final qc approval as of 10-jan-2020.

Manufacturer Narrative

Evaluation summary: we asked the customer whether the culture test was necessary or not, but we did not receive a reply and could not obtain any information.The reason for reporting the suspicion of biofilm is unknown because information including the customer's use case was not obtained.There have been no similar complaints in this scope, and it has been confirmed that there will be no problems if reprocessing is done according to ifu.Since there have been no similar complaints from the facility since then, it is determined that the equipment was not the cause.Correction information.G6: follow up #1.H2: type of follow up.H6: coding changed based on the investigation result.

• Brand Name: PENTAX
• Type of Device: VIDEO NASO-PHARYNGO-LARYNGOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, 196-0 012; JA 196-0012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, 196-0 012; JA 196-0012
• Manufacturer Contact: william goeller (temporary) ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 9576942
• MDR Text Key: 178958930
• Report Number: 9610877-2020-00016
• Device Sequence Number: 1
• Product Code: EQN
• 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: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VNL-1570STK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1