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 Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical was made aware of a complaint from a customer stating "cannot pass dilation balloon down scope" involving pentax model eg-2990i/serial (b)(4).The device was returned to pentax medical for evaluation after the event occurred.The pentax endoscope technician confirmed a piece of black material lodged inside the operation channel.This finding confirmed the customer's complaint.Other inspectional findings included: passed dry leak test; passed wet leak test; control body grip scratched; pve connector housing scratched.Pentax medical contacted the initial reporter to gather additional information about the event.A response was received from the initial reporter on 06/28/2016 stating the surgeon was unable to pass a balloon dilator through the gastroscope during the procedure, and could not identify the cause.The initial reporter also stated the portion of the procedure during which the gastroscope with the obstruction lodged inside was used on the patient lasted approximately 20 minutes.The camera on the gastroscope was functional and the time spent visualizing the area was not affected by the obstruction.The procedure lasted a few minutes longer than it would have due to the surgeon's unsuccessful attempt to pass the balloon dilator, and also due to switching out the gastroscope with another.The procedure was successfully completed with a second gastroscope.Because of this, the patient remained anesthetized for a few minutes longer.The initial reporter confirmed the patient has not experienced or reported any symptoms of illness, injury, or any other adverse effects as a result of the event.In addition, the patient has not been recalled for further screening, however, the facility will notify the patient and offer screening and treatment, if necessary.Prior to the event, the facility stated the standard cleaning process testing results indicated that all channels were clear and did not identify an obstruction.Pentax medical completed repairs on the gastroscope involved in the event, which included replacement of the following components: o-rings and seals; bending rubber; operation channel.The gastroscope was shipped back to the customer on 03/01/2016.Pentax medical is currently investigating this event.

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 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.On (b)(6) 2016, a device history review was performed confirming the endoscope 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.

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2017, pentax medical closed the investigation and considers this medwatch closed since the investigation concluded the cause of the stuck accessory was likely caused by user error.

• 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: 5810211
• MDR Text Key: 50390645
• Report Number: 9610877-2016-00130
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2017,06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 02/08/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2017
• Distributor Facility Aware Date: 06/28/2016
• Device Age: 54 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2017
• Initial Date Manufacturer Received: 06/28/2016
• Initial Date FDA Received: 07/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/22/2017; 05/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2012
• 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