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

Model Number EG-2790I

Device Problem Device Issue (2379)

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

Event Date 04/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical was made aware of a report stating the physician " was doing a colonoscopy with a pediatric upper scope and the scope got stuck in the patient.The patient ended up going to surgery to have it removed.The scope has a definite kink in it and will be sent in.They had to do a lot of manipulation during the procedure and the patient's anatomy was difficult so at what point the scope was kinked is unclear", involving pentax model video gastroscope eg-2790i/serial (b)(4).Additional information was received by the facility which stated the event prolonged the patient's stay in the hospital.The patient has since been discharged and recovering well from surgery.Patient information (i.E.Identifier, age, weight, and sex) was requested, however, not provided.In addition, the facility stated the gastroscope passed all pre-procedural inspection checks before use.The gastroscope was returned to pentax medical for evaluation.The inspectional findings included: a severe crush at stage 2 of the insertion tube; up angulation decreased; down angulation decreased; blocked primary operation channel; primary operation channel crimped at biopsy inlet t-piece; cracked right light carrying bundle distal cover glass; clogged air nozzle; right/left angulation knob play; up/down angulation knob play; left angulation decreased; right angulation decreased; a cut on the control body root brace; wet/dry leak tests passed.Pentax gastroscopes are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract.This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, and duodenum.These instruments are introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.The instructions for use for gastroscopes clearly state "never use these endoscopes for any purpose other than that for which they have been designed." therefore, off label use was the direct cause of this reportable event.

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical received voluntary medwatch mw5062108.The event description on the voluntary medwatch states "patient undergoing a colonoscopy.The scope was advanced roughly 80cm from the anal verge, but could not be advanced further.The gastroscope could only be withdrawn till 65 cm from the anal verge and then it got stuck.Aq colorectal surgeon was called who performed an exploratory laparoscopy for laparotomy, lysis of adhesions and extraction of entrapped scope from left colon".The voluntary medwatch made reference to pentax model ec-2790i.Pentax medical followed up with the initial reporter who acknowledged the error on the voluntary medwatch and on (b)(6) 2016 confirmed the device involved in the event as pentax model eg-2790i/serial (b)(4).Pentax medical completed repairs on the gastroscope involved in the event, which included replacement of the following components: o-rings and seals.Insertion flexible tube.Distal end assy with tubes.Bending rubber.Angle wire.Adjusting collar.Angle wire with coat.Rl pulley assy.Ud pulley assy.Segment attaching screw.Segment assy attaching screw.Distal set screw m1.2 special.Spacer.Root brace rubber lg body.Lg-column/side-cover holding screw.The gastroscope was shipped back to the customer on 05/19/2016.

Manufacturer Narrative

(b)(4) (exemption number e2015036).

Event Description

A device history review was performed on (b)(6) 2017 confirming the gastroscope was manufactured under normal conditions, passed all required inspections, and was released accordingly.Also, there were no reworks or concessions and 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: 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 ; 2015712300
• MDR Report Key: 5655514
• MDR Text Key: 45191650
• Report Number: 9610877-2016-00084
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2017,04/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: EG-2790I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2017
• Distributor Facility Aware Date: 04/14/2016
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2017
• Date Manufacturer Received: 06/07/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• 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
• Patient Outcome(s): Hospitalization; Required Intervention