MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; LINEAR ULTRASOUND VIDEO GASTROSCOPE 3.8C

Model Number EG-3870UTK

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

This complaint is being processed in accordance with dpa-qip-mdr decision backlog management plan.

Event Description

Pentax medical became aware of a report for an event which occurred in the usa stating, " elevator broken (no angulation)" involving pentax model eg-3870utk/serial (b)(4).No further information was provided at the time of the report.Pentax made 3 good faith effort attempts to collect additional information from the facility.The facility contact did not provide any additional information.Pentax service inspectional findings included: unit tested all function pass, passed wet leak test, passed dry leak test.Repairs were not required; therefore, the device was returned to the loaner inventory.This event meets the requirements for fda reportability; however, submission of this report does not constitute an admission that medical personnel, user facility, importer, manufacturer or product caused or contributed to the event.

• Brand Name: PENTAX
• Type of Device: LINEAR ULTRASOUND VIDEO GASTROSCOPE 3.8C
• 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: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12353826
• MDR Text Key: 267667526
• Report Number: 9610877-2021-00762
• Device Sequence Number: 1
• Product Code: ODG
• UDI-Device Identifier: 04961333135899
• UDI-Public: 04961333135899
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182004
• 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: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-3870UTK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Manufacturer Received: 08/06/2020
• Initial Date FDA Received: 08/23/2021
• 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