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

Model Number EG-2990I

Device Problem Device Reprocessing Problem (1091)

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

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical was made aware of a report which stated "black rubber piece about an inch long came out of scope and into a patient" involving pentax model eg-2990i/serial (b)(4).The video gastroscope (pentax model eg-2990i/serial (b)(4)) was returned to pentax medical for evaluation after the event occurred.The black material was also returned to pentax medical for identification.The pentax medical service inspectional findings included: -operation channel, primary mild scratch inside.-passed wet/dry leak test.-umbilical cable bump.-lightguide prong cover glass set loose.-insertion tube bump at stage 1.-insertion tube bump at end of root brace.-suction tube mild resistance.-insertion tube mild crush at stage 3.Pentax medical service confirmed the black material returned by the facility was not part of the video gastroscope.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, 15-18mm cre pro wireguided balloon, model 5870.The facility stated on 07/28/2017 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 dismissed 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.-distal end assy with tubes.-adjusting collar.-bending rubber.-distal attaching plate.-segment assy attaching screw.-insertion flex tube.-angle wire.-light guide cable.The video colonoscope was returned to the customer on 08/03/2017.

Manufacturer Narrative

Hoya corporation pentax (b)(4), specification developer, registration no.9610877 pentax of america, inc., importer, registration no.2518897 pentax of america, inc.(importer) is submitting the report on behalf of hoya corporation pentax (b)(4) (exemption number e2015036).

Event Description

On 17-nov-2017, pentax medical received voluntary medwatch report# (b)(4) from the fda via postal mail.The voluntary medwatch described the event as follows: patient was having an egd.During the egd the physician stated that he felt like biopsy forceps was difficult to pass down the biopsy channel.After biopsy was obtained, the doctor complained that the scope was no longer able to hold air, and a black piece of rubber was seen in the patient's stomach.The piece of rubber was retrieved and was intact, removed with ease from the patient's stomach using a biopsy forceps.No harm was done to the patient.Scope was pulled out and checked and found to have a large inner channel leak and was sent to the biomed department to prepare to be sent for repair.The physician was satisfied that all rubber from the inside of the scope was removed intact from the patient's stomach.

Manufacturer Narrative

Hoya corporation pentax (b)(4), specification developer, registration no.9610877.Pentax of america, inc., importer, registration no.2518897 pentax of america, inc.(importer) is submitting the report on behalf of hoya corporation pentax (b)(4) (exemption number e2015036).

Event Description

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.The instructions for use for this model endoscope instructs the user to "maintain view of the accessory during advancement, use and withdrawal of the device".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
• 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: 6788852
• MDR Text Key: 82560446
• Report Number: 9610877-2017-00411
• 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,Followup,Followup
• Report Date: 03/09/2018,07/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-2990I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2018
• Distributor Facility Aware Date: 07/13/2017
• Device Age: 67 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2018
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 11/17/2017; 11/17/2017
• Supplement Dates FDA Received: 12/15/2017; 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2011
• 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): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 149