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

Model Number EC-3890LI

Device Problem Device Issue (2379)

Patient Problem Bacterial Infection (1735)

Event Date 11/27/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical became aware of a report on (b)(4) 2017 stating a patient got c-diff after a procedure performed with pentax model ec-3890li/(b)(4), therefore the customer wants to have the device evaluated to ensure there are no defects.The device was returned to pentax medical for evaluation.The pentax medical service inspection findings included the following: operation channel - primary severe scratch inside, passed wet/dry leak tests, water nozzle glue missing, air nozzle glue missing, control body grip scratched.Pentax medical submitted a good faith effort to the customer in order to gather details on the patient, event, and reprocessing techniques followed at the facility.

Event Description

Additional information on the patient and event was received from the facility on 02-jan-2018.The information stated the patient underwent a colonoscopy procedure with pentax model ec-3890li/serial (b)(4) on (b)(6) 2017.The patient returned later that day to the emergency department with abdominal pain and diagnosed with c.Diff infection.Treatment provided to the patient as follows: ct abd/pelvis; ekg; blood cx; c.Diff toxin; cbc; cmp; amylase; lipase; troponin; u/a; istat lactate; pt/inr; wbc stool, cipro 400 mg/100 ml ivpb and flagyl 400 mg/200 ml ivpb; lr 1,000 ml bolus: all done in emergency department.The facility stated the event was not considered life-threatening.The patient was sent to the clinical decision unit for observation.The facility also stated the patient has been discharged and will not be recalled for further screening.

Manufacturer Narrative

(b)(4).(exemption number e2015036).

• 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: 7135079
• MDR Text Key: 95454831
• Report Number: 9610877-2017-00684
• 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: other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018,11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• 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: 12/04/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2018
• Distributor Facility Aware Date: 11/29/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2018
• Date Manufacturer Received: 01/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR
• Patient Weight: 59