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

Model Number EG-290KP

Device Problem Use of Device Problem (1670)

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

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical became aware of a report for an event which occurred in (b)(6) at the centre hospitalier (b)(6), stating, "during the endoscopy, blocking of the levers.Impossibility to get out the endoscope as bent distal by the deflection.Handling ++ to try to straighten this blocked deflection until broken, then removing the endoscope.Risk of perforation." no further information regarding the event or the patient involved was received at the time of the report.The device involved in the event was returned to pentax for evaluation.The inspectional findings, as reported by pentax europe, state the first impression of the affected scope is good.The scope is tight.The investigation of the pulley wires (mechanism to angulation wheel) and the angle wires (mechanism to segment) is without any finding.This area is in good condition.Also, the first disassembling steps of the angulation shows the parts in good condition.The up/down wheel shows chemical deposit and loosened screws.Therefore, the axis was loosened and the angulation without function.In addition, the damage has arisen over a longer period of time, because all screw holes are broken and the screw holes have no thread.Pentax europe concluded the scope must be checked prior to use.The defects suggest a longer wear period.The deterioration of the angulation must have been noticed by the user under any circumstance and the endoscope should have been serviced.So, it seems as if the user has not check the scope prior to use.We assume a user error.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE
• 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: 6477077
• MDR Text Key: 72423058
• Report Number: 9610877-2017-00023
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K962897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/10/2017,03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-290KP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/10/2017
• Distributor Facility Aware Date: 03/21/2017
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2017
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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