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

Model Number EC34-I10F

Device Problem Device Issue (2379)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This mdr was initiated as part of a capa-driven remediation effort related to filing of mdrs for complaints/events outside of the us (ous).As part of this remediation, pentax medical performed a retrospective mdr assessment of all ous events/complaints received since october 2015.The retrospective assessment of this event prompted pentax medical to file this report.This product is not sold and or distributed in the usa, therefore there is no 510(k).Event problem and evaluation codes (b)(4).

Event Description

Pentax medical was made aware of a report for an event which occurred outside the usa ((b)(6)) stating "during a bowel scope list a patient needed some biopsies taken the nurse endoscopist attempted to pass the biopsy forceps down the colonoscope but was unable to pass out the end of the scope, she tried gently pushing several times but was not able to pass the biopsy forceps out.The scope was removed from the patient and when passing the forceps down the colonoscope channel again an 8 inch metal rod came out of the end of the scope it was realized that it was the metal rod inside the channel which was preventing the biopsy forceps passing through.No injury was caused because when the biopsy forceps would not pass down the colonoscope channel the colonoscope was removed from the patient before proceeding to pass the biopsy forceps through.

Manufacturer Narrative

Mfr site and source continued: hoya corporation pentax tokyo office, specification developer, registration no.9610877 pentax of america, inc., importer, registration no.(b)(4).Pentax of america, inc.(importer) is submitting the report on behalf of hoya corporation pentax tokyo office (exemption number e2015036).

Event Description

The user facility conducted an investigation which included reports from the traceability system which highlighted the colonoscope had come back from repair.The reports also showed the colonoscope passed through the rapid aer and was placed in the drying cabinet in endoscopy.Pentax was informed of the event and requested return of the colonoscope and the metal rod for investigation.The scope and metal rod were received by pentax.Then contacted the hospital sterile service unit to inform them the metal rod belonged to pentax and is used during the repair process.The user facility also contacted the endoscope washer manufacturer to inform them of the event.The hospital sterile service unit informed all staff that all endoscopes received back from pentax after repairs must be manually washed.After the user facility investigation was completed, the user facility submitted an adverse incident report to their regulating authority, medicines and healthcare products regulatory agency (mhra).Pentax re-trained service staff in order to ensure all devices will be checked adequately to prevent recurrence.The colonoscope was repaired and returned to the user facility.On 13-feb-2018, device history review was performed confirming the 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.No further information has been received for this event, therefore, pentax 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
• MDR Report Key: 5805099
• MDR Text Key: 50106463
• Report Number: 9610877-2016-00149
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 04/06/2018,04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: EC34-I10F
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2018
• Distributor Facility Aware Date: 04/19/2016
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2018
• Date Manufacturer Received: 04/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1