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

Model Number EC-3890LI

Device Problems Device Reprocessing Problem (1091); Device Issue (2379)

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

Event Date 06/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Mdr 9610877-2016-00127 and 9610877-2016-00128 were submitted for the other patients involved in this event.

Event Description

Pentax medical received a report for an event which occurred in (b)(6) stating the facility will be sending back one of their endoscopes (pentax model ec-3890li/(b)(4)) for a repair and are requesting a thorough examination of the scope with a detailed report of pentax findings.The facility had an incident where a clip (boston scientific) somehow became lodged within the scope, it remained inside the scope during 3 sterilization processes and patient uses.It was then dislodged when a snare was placed down the working channel and the clip came out inside the patient identified in this report.The clip was removed from the patient.As per the hospital, there were no patient consequences as a result of the event.The colonoscope involved in the event was returned to pentax (b)(4) for inspection and evaluation.Pentax (b)(4) completed evaluation of the device involved in the event and confirmed no failures were found which could have contributed to this event.Repair was completed on the colonoscope in which the fwd body trim collar was replaced.Pentax medical contacted the initial reporter on 06/21/2016 for additional information on the event and the patient identified in this report.No additional information has been received from the initial reporter.Pentax (b)(4) submitted a mandatory medical device problem reporting form (reporter file no.Mdr 16-00101a-c) to (b)(6) for this event.Pentax medical is currently investigating this event.

Manufacturer Narrative

(b)(4).

Event Description

Pentax (b)(4) submitted a final report to health (b)(4) on 08/15/2016.The report states the endoscope was returned to the customer on 07/15/2016.In addition, the results of the investigation performed by pentax (b)(4) confirmed the issue could not be duplicated and the endoscope performed properly according to the instructions for use.

Manufacturer Narrative

(b)(4).

Event Description

A device history review was performed on (b)(6) 2016 confirming the endoscope 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.Since the endoscope function as intended and the root cause of the stuck clip is unknown due to no failures were found during evaluation that could have resulted in the event.It is reasonable to conclude that this event may have occurred due to user error or the event may be an anomaly.Pentax medical closed the investigation 03/24/2017 and 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: krishna govindarajan ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 5799749
• MDR Text Key: 49743699
• Report Number: 9610877-2016-00126
• 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: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2017,06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EC-3890LI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2017
• Distributor Facility Aware Date: 06/16/2016
• Device Age: 60 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/11/2017
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2012
• 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