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

Model Number EG-3830UT

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2015

Event Type  malfunction  

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 october 2015.The retrospective assessment of this event prompted pentax medical to file this report.(b)(4).

Event Description

Pentax medical was made aware of a report for an event which occurred outside the usa stating "the channel to allow the exit of the needle is out of alignment (jumping needle)" involving pentax model eg-3830ut/(b)(6).

Manufacturer Narrative

Hoya corporation pentax (b)(4) office, specification developer, registration no.(b)(4) pentax of america, inc., importer, registration no.(b)(4).(exemption number e2015036).

Event Description

The manufacturer is aware of this type of malfunction and previously initiated a field safety corrective action amending the instructions for use to clarify the method for advancing an accessory in pentax ultrasound video gastroscope model eg-3830ut and for two other devices of similar design (pentax ultrasound fiber gastroscope model fg-36ux and pentax ultrasound video gastroscope model eg-3630u).This action was completed 01-dec-2014.On 06-feb-2018, a device history review was performed which confirmed the ultrasound video gastroscope was manufactured under normal conditions.A nonconformance was found during in-process inspection which was reworked.The device then passed all required inspections, and was released accordingly.In addition, the dates of approval for shipment and actual date shipped were confirmed.No further information has been received for this event, therefore, pentax medical considers this medwatch report closed.

• Brand Name: PENTAX
• Type of Device: ULTRASOUND 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 Key: 5806472
• MDR Text Key: 50130931
• Report Number: 9610877-2016-00141
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• PMA/PMN Number: K041397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 03/09/2018,11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: EG-3830UT
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2018
• Distributor Facility Aware Date: 11/12/2015
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2018
• Date Manufacturer Received: 11/12/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1