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

Model Number EG-3490K

Device Problem Device Issue (2379)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This mdr was initiated as part of a capa-driven remediation effort related to filing of mdrs for complaints/events outside of the us (ous).As part of this remediation, pentax medical performed a retrospective mdr assessment of all ous events/complaints received since jan 2013.The retrospective assessment of this event prompted pentax medical to file this report.

Event Description

Pentax medical was made aware of a report received from pentax (b)(4) stating "injury to stomach lining during exam involving pentax model ec-3490k/serial (b)(4)".

Manufacturer Narrative

Hoya corporation pentax (b)(4) office, specification developer, registration no.9610877 pentax of america, inc., importer, registration no.2518897.Pentax of america, inc.(importer) is submitting the report on behalf of hoya corporation pentax (b)(4) office (exemption number e2015036).

Event Description

The gastroscope was returned to pentax (b)(4).The inspection found a broken distal end body which was the result of normal wear and tear.Pentax (b)(4) queried the facility for additional information regarding the event and patient condition.No response was received from the facility.On 21/jul/2016, device history review was performed confirming the gastroscope was manufactured under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and the dates of approval for shipment and actual date shipped were confirmed.No further information has been received for this event, therefore pentax considers this medwatch report closed.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo 196-0012, ja, ; JA
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo 196-0012, ja, ; JA
• Manufacturer Contact: matthew vernak ; 3 paragon drive; montvale, NJ 07645 ; 2015712300
• MDR Report Key: 5498964
• MDR Text Key: 40279504
• Report Number: 9610877-2016-00071
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2017,01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: EG-3490K
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2017
• Distributor Facility Aware Date: 01/14/2014
• Device Age: 57 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2017
• Date Manufacturer Received: 01/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2009
• 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): Other