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

Model Number EC-3890LI

Device Problems Device Issue (2379); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2014

Event Type  malfunction  

Manufacturer Narrative

According to the maude adverse event report 4079965, the scope was returned to manufacturer on 08/28/2014 but since no model number, user facility contact information, nor serial number was provided, confirmation cannot occur.Therefore, for the results code, "none" was chosen as the best code and "no information" was chosen as best answer to the question of whether device was evaluated by manufacturer.(b)(4).

Event Description

On 09/28/2015 pentax medical became aware of maude adverse event report number mw4079965 stating a colonoscope (model unknown, serial number unknown) was involved in a product malfunction.Specifically, the report stated: "while performing a colonoscopy and snaring a polyp, staff heard a noise and the screen went black.Staff initially thought it was the processor and the cart was switched, but this did not work.The scope was switched out and everything worked fine".According to the report, the scope was returned to manufacturer on 08/28/2014.After reviewing all colonoscopes returned between 08/28/2014 to 08/30/2014, a definitive user facility, model number, nor serial number for this complaint was not located in our internal enterprise resource planning (erp) system.

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical received mw5044815 (b)(4) via postal mail on 10/28/2015.The serial number on the report for the colonoscope was provided as (b)(4).After a review of the service order history for this customer in our internal enterprise resource planning (erp) system, this serial number was not able to be matched to any of the serial numbers on devices returned from the facility in 2014.In addition, 09/26/2014 is the date of event provided on the voluntary report, however, this date does not coincide with date of return for the colonoscope provided as (b)(6) 2014.Good faith effort attempts to the facility were made via telephone calls on 11/12/2015, 11/17/2015 and 11/20/2015, however, further information or clarification regarding the event details have not been received at this time.

Manufacturer Narrative

(b)(4).

Event Description

After reviewing all products with serial number (b)(4) in our internal erp system, it was discovered that the video colonoscope involved in the event was billed to (b)(6) center, however, the video colonoscope was sold to and shipped to (b)(6) hospital.It was also discovered that the customer notified pentax on (b)(6) 2014 with a reported concern of "clicking noise coming from the scope".Additional correspondence received from the customer at that time stated "while plugged into processor-screen froze-processor made horrible noise-clicking; plugged into 2nd processor-repeated the same noise and clicking".The video colonoscope was received by pentax medical on (b)(6) 2014 for evaluation.The pentax service inspection findings included the following: passed wet/dry leak tests.Insertion tube coating peeling off at stages 1, 2, and 3.Vertical lines in image.Ccd circuit board loose center connection.Umbilical cable single has mild scratch.A device history review was performed on (b)(6) 2017 confirming the video colonoscope 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.As per the instructions for use for model ec-3890li, "check the endoscopic image and confirm that it is of acceptable quality for clinical use.Refer also to the owner's manual supplied with the pentax video processor for inspection of the image quality." based on the information received from the complainant and the investigation performed by pentax medical it is reasonable to conclude the faulty ccd circuit board was the cause of the event.Repairs were performed on the video colonoscope involved in the event, which included replacement of the following components: o-rings and seals.Distal end assy with tubes.Adjusting collar.Bending rubber.Insertion flex tube.Root brace rubber imp-1.Angle wire.R/l and u/d pulley assy.Pcb for ccd drive.Electrical connector assy.Insertion tube attaching nut imp-1.Fwd body frame (2) imp-1.The video colonoscope was shipped back to the facility on (b)(6) 2014.No further information has been received for this event, therefore, pentax medical considers this medwatch report closed.

• Brand Name: PENTAX
• Type of Device: VIDEO COLONOSCOPE
• 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: krishna govindarajan ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 5166538
• MDR Text Key: 29074729
• Report Number: 9610877-2015-00009
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131855
• 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: 05/11/2017,09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC-3890LI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2017
• Distributor Facility Aware Date: 09/28/2015
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/11/2017
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1