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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE

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HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE Back to Search Results
Model Number EG29-I10
Device Problem Ventilation Problem in Device Environment (3027)
Patient Problem Chemical Exposure (2570)
Event Date 11/09/2019
Event Type  Injury  
Event Description
Pentax medical was made aware of a complaint on (b)(6) 2019, that occurred during reprocessing on (b)(6) 2019 in (b)(6).The reported complaint that two technicians underwent "exposure to high isopropyl alcohol vapors while pre-sterilizing scopes during the alcohol flush" involving multiple pentax medical i10 series endoscopes.After being made aware of the events on the final day of the demo, (b)(6) 2019, pentax (b)(6) provided the option to the hospital to no longer use alcohol to flush and move to air.The first technician was assessed and was admitted to the emergency room, although the condition was not considered life threatening.The tech was assessed and referred to an ent [ear, nose, throat specialist].The patient was not recalled for further screening and the technician is still symptomatic.When asked if the technician was wearing proper ppe (personal protective equipment), inadequate ventilation was noted.The technician was exposure to s40 sterilant on october 30, 2019 following an equipment malfunction.The endoscopes involved were a group of demo units reprocessed including the following models and serial numbers.Ec38-i10nl, (b)(4) and eg29-i10, (b)(4).Since it was a demonstration, the exact models and serial numbers processed by each technician were not recorded in detail so it remains unclear which endoscopes were reprocessed by which technician.As there was no suspected malfunction of the pentax medical endoscope only one mdr report will be filed for each technician for both the colonoscope and gastroscope product families.Device history record (dhr) reviews were performed for each endoscope serial number and are documented below.On 13-dec-2019, a device history record (dhr) review was performed under (b)(4), the dhr review confirmed all of the following endoscopes were manufactured under normal conditions, passed all required inspections, and were released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed.Below are the manufacturing and ship dates for each serial number: model: ec38-i10nl, serial number: (b)(4), manufacturing date: 04-apr-2017, shipment date: 18-may-2017; model: ec38-i10nl, serial number: (b)(4), manufacturing date: 21-apr-2017, shipment date: 18-may-2017; model: ec38-i10nl, serial number: (b)(4), manufacturing date: 04-apr-2017, shipment date: 18-may-2017; model: ec38-i10nl, serial number: (b)(4), manufacturing date: 10-oct-2017, shipment date: 11-oct-2017; model: ec38-i10nl, serial number: (b)(4), manufacturing date: 13-oct-2017, shipment date: 17-oct-2017; model: ec38-i10nl, serial number: (b)(4), manufacturing date: 13-oct-2017, shipment date: 17-oct-2017.Model: eg29-i10, serial number: (b)(4), manufacturing date: 24-jun-2017, shipment date: 24-jun-2017; model: eg29-i10, serial number: (b)(4), manufacturing date: 11-jan-2018, shipment date: 12-jan-2018; model: eg29-i10, serial number: (b)(4), manufacturing date: 11-jan-2018, shipment date: 12-jan-2018; model: eg29-i10, serial number: (b)(4), manufacturing date: 11-jan-2018, shipment date: 12-jan-2018.The investigation is currently in-process.
 
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Brand Name
PENTAX
Type of Device
VIDEO GASTROSCOPE
Manufacturer (Section D)
HOYA CORPORATION PENTAX TOKYO OFFICE
tsutsujigaoka 1-1-110
akishima-shi
tokyo, 196-0 012
JA  196-0012
MDR Report Key9467991
MDR Text Key188814543
Report Number2518897-2019-01238
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/13/2019,11/16/2019
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? No
Device Operator Health Professional
Device Model NumberEG29-I10
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/13/2019
Distributor Facility Aware Date11/16/2019
Event Location Hospital
Date Report to Manufacturer12/13/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age33 YR
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