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

Model Number EG16-K10

Device Problems Failure to Disconnect (2541); Device Damaged by Another Device (2915)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/25/2021

Event Type  malfunction  

Event Description

Pentax medical became aware of an event on 25-feb-2021 that occurred in (b)(6).The reported complaint of "forceps mouth brush clogging", involving pentax medical video gastroscope model eg16-k10, serial number (b)(4) did not contribute to or cause a serious injury or death of a patient or user.Pentax medical (b)(4) performed good faith effort to the user and confirmed the endoscope was used during the procedure, and there was no delay in the procedure which medical intervention was required.There was resistance felt during reprocessing and then the cleaning brush became stuck in the channel.On 30-apr-2021, pentax medical (b)(4) responded to an email request for additional information.They responded stating that the pentax medical cleaning brush model cs-6021t, unknown lot number, was damaged and clogged during reprocessing.Instructions for use(ifu), includes the following warning section 2-1-3, 3) "after using operational/cleaning accessories (e.G., forceps, needles, snares, brushes etc.) with the endoscope, carefully check that all accessories are intact and that no parts have fallen off and become lodged within the endoscope's instrument/suction channel.Furthermore, ensure that any therapeutic devices (e.G., clips, stents, etc.) passed through the channel are accounted for after use.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.On 9-mar-2021, a device history record(dhr) review for model eg16-k10, serial number (b)(4)was performed under (b)(4), the dhr review confirmed the endoscope was manufactured on 18-sep-2012 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 for 18-sep-2012.A device history record(dhr) review could not be completed for for pentax medical cleaning brush model cs-6021t as the lot number is unknown.During evaluation of the returned endoscope, a cleaning brush (cs6021t) was found stacked at the entrance of the forceps opening.The instructions for use(ifu) states that the forceps opening should be cleaned using cs-c9s, but this occurred because cs6021t was inserted.The endoscope was repair and approved on 19-may-2021.

Manufacturer Narrative

(b)(4).Mdr 9610877-2021-00102 will be submitted for the pentax medical video gastroscope model eg16-k10, serial number (b)(4).Mdr 9610877-2021-00103 will be submitted for the pentax medical cleaning brush model cs-6021t, unknown lot number.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 196-0012 ; JA
• MDR Report Key: 12096345
• MDR Text Key: 281610354
• Report Number: 9610877-2021-00102
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG16-K10
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1