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

Model Number EG-2990I

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical was made aware of a complaint on (b)(4) 2017 which stated 'cannot put brush in - blocked' for video gastroscope model eg-2990i/serial (b)(4) received through the pentax medical service department.No other information was provided at the time of the report.The video gastroscope was returned to pentax medical for evaluation.The pentax endoscope technician confirmed a screw stuck inside biopsy inlet port causing blockage in the primary channel.This finding confirmed the customer's complaint.Other inspectional findings included: -dry/wet leak tests failed.-leak at air/water nozzle.Pentax service confirmed the screw was a pentax part.The channel and biopsy barrel needed to be removed from the t-piece to remove the pentax screw.In addition, pentax service stated the pentax screw was somehow dropped into the t-piece during repair and during final assembly, the biopsy barrel was attached trapping the screw.Pentax medical contacted the facility to gather additional information.A response was received from the initial reporter on 27-nov-2017 stating the event occurred on (b)(6) 2017 when the physician became aware of the blockage during the procedure prior to any accessory being utilized.The blockage was discovered when the physician was unable to place biopsy forceps down the channel due to resistance.The gastroscope was removed immediately when the blockage was discovered and sent into pentax for service.No injury or issues occurred with the patient.The facility also confirmed that this was the first time the gastroscope was used for a procedure since received from pentax for a previous repair on 19-oct-2017.In addition, the gastroscope was high level disinfected prior to being used for the first time on (b)(6) 2017.Pentax medical replaced the following components on the video gastroscope involved in the event: -o-rings and seals.-distal end assy with tubes.-adjusting collar.-bending rubber.-distal attaching plate.-segment assy attaching screw.-segment attaching screw.-angle wire.-r/l and u/d pulley assy.-a/w supply tube retaining collar.-rl lock knob retaining nut cover.The video gastroscope was returned to the customer on 20-nov-2017.

• Brand Name: PENTAX
• Type of Device: 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: 7145752
• MDR Text Key: 96115773
• Report Number: 9610877-2017-00683
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/26/2017,11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: EG-2990I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/26/2017
• Distributor Facility Aware Date: 11/27/2017
• Event Location: Other
• Date Report to Manufacturer: 12/26/2017
• Date Manufacturer Received: 11/27/2017
• 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