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

Model Number EG27-I10

Device Problem Device Reprocessing Problem (1091)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 07/28/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical was made aware of a report which stated the scope being used by the doctor and a piece of black rubber was pushed through into a patient's stomach during an egd and was retrieved involving pentax model eg27-i10/serial (b)(4).The video gastroscope was returned to pentax medical for evaluation after the event occurred.The black material was not returned to pentax medical.The pentax medical service inspectional findings included: operation channel, primary slice by accessory, passed wet/dry leak tests, lightguide prong cover glass set loose, primary operation channel crimped at biopsy inlet t-piece, fluid invasion not observe in pve connector or in control body, channel improperly installed (gap distal body opening), insertion tube buckles and scratches at stage 1.Pentax medical followed up with the facility to gather additional information.In response to the follow up, the territory manager visited the facility on 07/28/2017 to aid in the facility investigation.The facility identified the material as a piece of a boston scientific dilation balloon 18-20 ref # (b)(4).Additional information received from the facility on 08/08/2017 stated that no debris remained in the patient after the material was retrieved.The patient did not report any symptoms of illness after the event occurred, will not be recalled for further screening, and has since been discharged from the hospital.During the visit, the territory manager reminded the customer on inspecting each accessory to ensure no material remains in the endoscope after use.Repairs were performed on the video gastroscope which included replacement of the following components: o-rings and seals, insertion flexible tube, distal end assy with tubes, bending rubber, adjusting collar, r/l and u/d pulley assy, segment attaching screw, segment assy attaching screw, angle wire, segment staycoil assy, staycoil collar.

Manufacturer Narrative

Hoya corporation pentax (b)(4) office, specification developer, registration no.(b)(4) pentax of america, inc., importer, registration no.(b)(4).(exemption number e2015036).

Event Description

The video gastroscope was shipped back to the customer on 29-aug-2017.On 06-apr-2016, pentax issued a u.S.Urgent field correction which is an ifu addendum for endoscopes with instrument channels.This addendum covers any operational/cleaning accessories and therapeutic devices which can become lodged in the endoscope's instrument channel.It reminds customers to carefully check that all accessories are intact, that no parts have fallen off and become lodged within the endoscope's instrument/suction channel and to ensure that any therapeutic devices (e.G., clips, stents, balloons, etc.) passed through the instrument channel and are accounted for after use.A device history review was performed on 11-dec-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 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
• MDR Report Key: 6822974
• MDR Text Key: 83724265
• Report Number: 9610877-2017-00414
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/12/2018,07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG27-I10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/12/2018
• Distributor Facility Aware Date: 07/28/2017
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2018
• Date Manufacturer Received: 07/28/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 90