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

Model Number EC38-I10L

Device Problems Disconnection (1171); Device Issue (2379)

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

Event Date 09/29/2015

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.(b)(4).

Event Description

Pentax medical was made aware of a report for an event which occurred outside the usa stating "the scope was broken during the colonoscopy.The insertion tube was lifted off, leaving the inside visible" involving pentax model ec38-i10l/sn (b)(4).No serious injury or death of a patient or user was reported.Upon further communication with pentax europe, it was confirmed that the insertion tube attaching nut became loose/disconnected during the procedure.

Manufacturer Narrative

G1,2 continued: hoya corporation pentax tokyo office, specification developer, registration no.9610877.Pentax of america, inc., importer, registration no.2518897.Pentax of america, inc.(importer) is submitting the report on behalf of hoya corporation pentax tokyo office (exemption number e2015036).

Event Description

The colonoscope was repaired by a distributor of pentax emea, therefore further evaluation could not be performed by the manufacturer.Communication between pentax emea and the distributor stated that "the insertion flexible tube was completely disconnected, the nut that has to attach it to the control body was unscrewed.Because of this, the insertion flexible tube root brace was broken." on 17-mar-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: 5806534
• MDR Text Key: 50128042
• Report Number: 9610877-2016-00135
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• PMA/PMN Number: K131855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 04/27/2018,09/29/2015

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: EC38-I10L
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2018
• Distributor Facility Aware Date: 09/29/2015
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2018
• Date Manufacturer Received: 09/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1