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

Model Number EC-3890LI

Device Problem Device Issue (2379)

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

Event Date 07/07/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).(exemption number e2015036).The 9610877-2016-00154 is being submitted for pentax model cs-6021t/lot 0031066.The 9610877-2016-00155 is being submitted for pentax model ec-3890li/serial (b)(4).

Event Description

Pentax medical was made aware of a report which stated the facility had an event where a cs-6021t tri-bristle brush broke off in an endoscope and was pushed out by an accessory during a live case with a patient.Pentax medical contacted the initial reporter to gather additional information on the event.Responses were received from the initial reporter stating the user discovered the cleaning brush fragment after it became dislodged from the endoscope and fell into the patient during a procedure performed with pentax model ec-3890li/serial (b)(4).The brush fragment was able to be retrieved from the patient.The facility confirmed this was the only patient exposed to the brush fragment.The brush fragment was disposed of by the facility.The facility also confirmed the patient is in good condition, did not report any symptoms of illness as a result of the event, and therefore was not recalled for further screening.In addition, the facility indicated the instructions for use for the colonoscope are followed.The facility performs cleaning manually and high level disinfection in an automated endoscope reprocessor.The facility verified no issues were encountered with the colonoscope during pre-procedural inspection.The device (pentax model ec-3890li/serial (b)(4)) was returned to pentax medical for evaluation.The pentax medical service inspection findings included the following: passed dry leak test, umbilical cable buckle at umbilical connector side, umbilical cable buckle at control body side, passed wet leak test, hole in #2 remote control button cover, insertion tube bump at end of root brace, up/down angulation knob play, right/left angulation knob play.The device (pentax model ec-3890li/serial (b)(4)) is currently at pentax medical under repair.

Manufacturer Narrative

(b)(4).(exemption number e2015036).9610877-2016-00154 is being submitted for pentax model cs-6021t/lot 0031066.9610877-2016-00155 is being submitted for pentax model ec-3890li/serial (b)(4).

Event Description

Pentax medical completed repairs on the colonoscope involved in the event, which included replacement of the following components: remote control button, light guide cable, o-rings and seals.The device was returned to the customer on 19/aug/2016.According to the instruction for use (reprocessing/maintenance), "to reprocess a pentax colonoscope with a single/common channel, prior to "automated reprocessing" check and confirm the lumens/channels to ensure that all internal channels are unblocked and/or unclogged." a device history review was performed on 05/oct/2017 confirming the scope 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.The facility filed medwatch mw5063343 with the fda for the brush involved in this event.The facility did not file a medwatch for the colonoscope involved in the event.Since no further information has been received for this event, 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: matthew vernak ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 5848477
• MDR Text Key: 51241150
• Report Number: 9610877-2016-00155
• 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: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/27/2017,07/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: Yes
• 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: 07/13/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/27/2017
• Distributor Facility Aware Date: 07/08/2016
• Device Age: 66 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2017
• Date Manufacturer Received: 07/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2010
• 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: 88 YR
• Patient Weight: 44