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

Model Number EE-1580K

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 05/05/2017

Event Type  Injury  

Manufacturer Narrative

Hoya corporation pentax (b)(4) is submitting the report on behalf of hoya corporation pentax (b)(4).This event involved one patient who experienced two separate allergic reactions with pentax model ee-1580k.Number 9610877-2017-00408 is being submitted for the first occurrence of an allergic reaction experienced by the patient.Number 9610877-2017-00409 is being submitted for the second occurrence of an allergic reaction experienced by the same patient.(exemption number e2015036).

Event Description

Pentax medical received a report for a patient who had an allergic reaction.The report stated "the patient had been scoped a number of times.On the last two scopes, the patient developed a severe rash and edema which is believed to have been confined to the head and neck area".The facility communicated allergy testing was performed on the patient which confirmed the following: negative for lidocaine allergy.Positive for rubber mix (severe reaction with blistering), thiuram mix (rubber accelerator used in manufacturing of rubber) and iodopropynyl butylcarbamate (preservative).The facility also communicated the patient has experienced reactions with sunscreens and latex is avoided since the rubber mix used during testing includes latex.The facility did not return the gastroscope to pentax medical for evaluation since no malfunction of the gastroscope was reported to have occurred.The facility requested pentax to provide information on whether the materials the patient tested positive for were used in the manufacturing of the gastroscope.A response was provided by the manufacturer which stated none of the materials the patient tested positive for are used in the construction of the patient contact surface of the gastroscope.This information was communicated to the facility.Additional information was received by the facility for both occurrences which stated the patient underwent a bronchoscopy procedure and over the next few hours the patient developed a regional rash and swelling in the neck and torso.The events were not considered life threatening and the patient did not go to emergency room nor was admitted to the hospital.No treatment was provided for the first occurrence.A medrol dose pack was given for the second occurrence.The facility also stated the patient is currently at baseline health.A serial number for the gastroscope was not provided by the facility.

Manufacturer Narrative

Report source continued: hoya corporation pentax tokyo office, specification developer, registration no.(b)(4).Pentax of america, inc., importer, registration no.(b)(4).Pentax of america, inc.(importer) is submitting the report on behalf of hoya corporation pentax tokyo office (exemption number e2015036).This event involved one patient who experienced two separate allergic reactions with pentax model ee-1580k.(b)(4) is being submitted for the first occurrence of an allergic reaction experienced by the patient.(b)(4) is being submitted for the second occurrence of an allergic reaction experienced by the same patient.

Event Description

A definitive serial number for the esophagoscope could not be determined, as a search of the pentax internal enterprise resource planning (erp) system shows the facility has multiple units of this model in their possession.Since the user did not return the unit for evaluation, and it functioned as intended, and the serial number for the esophagoscope could not be determined, a device history review and service history were unable to be performed.Pentax medical has not received further information for this event, and therefore, considers this medwatch report closed.

• Brand Name: PENTAX
• Type of Device: VIDEO ESOPHAGOSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo, 196-0 012; JA 196-0012
• MDR Report Key: 6784657
• MDR Text Key: 82489918
• Report Number: 9610877-2017-00409
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• PMA/PMN Number: K961564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/11/2018,07/13/2017

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?: No
• Device Operator: Physician
• Device Model Number: EE-1580K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2018
• Distributor Facility Aware Date: 07/13/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2018
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/10/2017
• Supplement Dates Manufacturer Received: 07/13/2017
• Supplement Dates FDA Received: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR