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

Model Number EG-3870UTK

Device Problem Failure to Align (2522)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Event problem and evaluation codes: (b)(4).

Event Description

Pentax medical was made aware of a complaint on (b)(6) 2017 stating the following "we have sent in our fna scopes multiple times for "md not being able to see needle".It is usually only with certain mds.We had this case yesterday where we used all 3 fna scopes and none of them was the md able to see the needle on all passes.When the scope is out we can see how the needle moves to the side vs staying in the middle.Can push back in place when out of the patient of course.I am not sure if you have had this issue before and can help out mds on how to control the scope to enable them to see the needle.In this case, dr.Li did come and we were able to see the needle after manipulating the scope." involving pentax video gastroscope ultrasound-linear array eg-3870utk/serial (b)(4).No serious injury or death of a patient or user, or delay in the procedure which would require medical intervention was reported by the user.On (b)(6) 2017, pentax medical followed up with the territory manager to inquire on when the units will be returned for further evaluation, no additional information was received.

• 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
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi; tokyo, 196-0 012; JA 196-0012
• Manufacturer Contact: matthew vernak ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 7447410
• MDR Text Key: 106982306
• Report Number: 9610877-2018-00114
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041397
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2018,07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• 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?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2018
• Distributor Facility Aware Date: 07/12/2017
• Device Age: 84 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2018
• Date Manufacturer Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1