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

Model Number EC-3490LI

Device Problem Material Separation (1562)

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

Event Date 10/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Since event information was received after the device repair, the device will not be returned.

Event Description

Pentax medical was made aware of a report for an event which occurred in (b)(6) stating while pentax model ec-3890li/serial (b)(4) was being used for a procedure, the bending rubber section split apart leaving black debris in the patient's colon.The colonoscope was withdrawn and the procedure was completed using another endoscope.Pentax (b)(4) submitted a report to (b)(6)(b)(4) stating "endoscope was sent in for repair with the comment of separation of sheathing exposing metal and nothing was mentioned on the document that this incident happened during the procedure.After we completed the repair and the sent the endoscope back to the customer we were notified that this incident (separation of sheathing) did happen during the procedure.We did ask the customer about the details of the incident and their feedback was the following "scope was being used for procedure, bending rubber section split apart leaving black debris in patient's colon.Scope was withdrawn & procedure was completed using another scope.No patient consequences as per the hospital."" in addition, the report stated, "the scope did come in for repair on oct 24th, 2016.It was repaired and shipped out on nov 11th.The customer didn't communicate to us that this incident happened during the procedure until nov 14th, 2016 therefore no additional investigation was done during the repair process.We are currently doing an investigation with the customer." pentax medical contacted the customer with regards to any medical intervention used on the patient.The customer stated the second scope was used to evacuate as much of the debris as possible.

Manufacturer Narrative

(b)(4).

Event Description

Pentax (b)(4) submitted a final report to health (b)(4) on (b)(6) 2017 (reporter file no.(b)(4)).In the report, pentax (b)(4) stated "we have tried obtaining additional information from the customer on the chemicals that are being utilized to clean and disinfect the endoscopes and whether these chemicals have been validated by the manufacturer to clean the endoscopes however no response was received despite sending 3 e-mails asking for the information.Therefore the root cause of the problem could not be determined.As no additional information was available from the customer, no corrective action is planned at this time.If additional information is provided, the complaint investigation will be reopened.".

• 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: 6173914
• MDR Text Key: 62361964
• Report Number: 9610877-2016-00176
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/17/2017,11/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EC-3490LI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2017
• Distributor Facility Aware Date: 11/14/2016
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2017
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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