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

Model Number VNL-1190STK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 03/21/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Mdrs 9610877-2017-00027, 9610877-2017-00031, 9610877-2017-00032, and 9610877-2017-00033 are being submitted for the 5 patients.Pentax video naso pharyngo laryngostroboscope product code is class 1, exempt from pma/510(k).

Event Description

Pentax medical was made aware of a report stating a patient experienced an allergic reaction during a procedure with a pentax endoscope.No further information on the patient or the endoscope was provided at the time of the report.A meeting was held with the facility on (b)(6) 2017 in which the facility stated several incidences have occurred during procedure with pentax video naso pharyngo laryngostroboscope model vnl-1190stk/serial number (b)(4).The instances have been occurring more frequently which prompted the facility to notify pentax.The events were described as follows: it was observed, down the nasal cavity and back into the nasal pharynx, that patients were experiencing reactions (thermal/chemical injuries/burns to the tissues).Patients have had to go to the er to receive treatment.In addition, during the meeting, the facility stated the instructions for use for this model endoscope is followed meticulously and there have been no issues with this endoscope since acquisition in (b)(6) 2013.The endoscope was removed from use after the event occurred on (b)(6) 2017 and sent into pentax for evaluation.The pentax medical inspection findings included the following: fluid invasion in segment section.Image alignment out.Vertical lines in image.Failed wet and dry leak test.Segment steel braid twisted.Up/down control knob/lever tension.Insertion tube severe coil shifting at stage 1.Bending rubber pinhole.Segment corroded.Video image has a white or red dot.Up angulation decreased.Bending rubber loose.Insertion tube buckles at stage 1.Insertion tube severe discoloration at stage 1.In addition, a dielectric strength test (the ability for the device to handle over voltage) and a patient leakage current test were performed (voltage going from endoscope to patient).The endoscope did fail ds test.The plc test was higher than normal but did not fail the test.Repairs were performed on the endoscope which included replacement of the following components: o-rings and seals.Distal end w/ccd-m pb-free/ntsc usa.Distal attaching pin.Insertion flex tube w/seg pb-free.Bending rubber.The device was returned to the customer on (b)(6) 2017.Additional information was received from the facility on (b)(6) 2017 indicating 5 patients experienced adverse reactions during procedure with the device identified in this mdr.A separate mdr is being submitted for each patient.The event details related to the patient identified in this mdr are as follows: topical anesthetic was applied to r nares.Distal chip scope was passed transnasally on right.Videostrobe exam completed.Patient's spouse called and stated that 1/2 hour post exam (approx 3:45pm-4pm), patient experienced itchiness and difficulty breathing.Md was not available; however, ma consulted slp.Slp indicated spouse should call rescue 911.Ma staff then called ent md.Ent md follow up - spouse gave patient 50 benadryl and called rescue.Ent md saw patient in emergency department.Examination: r nostril w/ significant edema, mild palate edema, mild pharyngeal edema and upper torso hives.No tongue, oc, bot, fvf, epiglottis or tvf or arytenoid edema.Decadon, pepcid, and benadryl were administered in emergency department w/ significant improvement in symptoms.Observed 1 hour and sent home with medrol dosepak.Follow up call at 10pm w/ improvement.Suspected reaction related to something on scope.Did clean the scope with alcohol pad before passing into nares.This had not been done in prior strobes.Allergy added to hospital and emr.Follow up call on (b)(6) 2017.Spouse reported patient doing well.Routine follow up w/ ent md on (b)(6) 2017.

• Brand Name: PENTAX
• Type of Device: VIDEO NASO PHARYNGO LARYNGOSTROBOSCOPE
• 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: matthew vernak ; 3 paragon drive; montvale, NJ 07645 ; 2015712300
• MDR Report Key: 6586138
• MDR Text Key: 75814734
• Report Number: 9610877-2017-00030
• Device Sequence Number: 1
• Product Code: EQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: REFER TO H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2017,04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VNL-1190STK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2017
• Distributor Facility Aware Date: 04/24/2017
• Date Report to Manufacturer: 05/23/2017
• Initial Date Manufacturer Received: 04/24/2017
• Initial Date FDA Received: 05/23/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 76 YR