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) 2018 stating the following "the fna needle is not coming out the end of the scope properly" 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.At the time of the complaint the unit was received at pentax medical with a complaint of remote control button leaking.Inspection was performed on the unit on (b)(6) 2018 on service order (b)(4) where the inspector found the following: ultrasound connector cable perforation, failed wet leak test, distal body chipped, leak at ultrasound connector cable, failed dry leak test, elevator knob play, scope case not received scope receive in box, # 1 remote control button cover cracked, balloon socket cylinder rubber covering torn, leak at # 1 remote control button cover, right angulation decreased, ccd laser filter lifting/ smearing, image spots.This unit is in the process of being repaired.

• 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: 7447405
• MDR Text Key: 106982435
• Report Number: 9610877-2018-00116
• 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: 04/20/2018,03/21/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• 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: 03/21/2018
• Device Age: 84 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2018
• Date Manufacturer Received: 03/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1