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

Model Number EG-290KP

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pentax medical became aware of a report for an event which occurred in germany stating during the examination, the angulation clamped at 200°.The doctor was able to remove the scope from the patient without any difficulties or risk to the patient.The segment was not so stiff to hurt a patient during the removal.No risk to health was observed.The video gastroscope was returned to pentax (b)(4) for evaluation.The evaluation performed by pentax (b)(4) confirmed the issue was a loosened screw.The screw was loosened and clamps between the two-angulation axes/knobs.The evaluation confirmed the angulation area was not in good condition.Pentax (b)(4) concluded possibly during the last repair performed on the device on (b)(6)2017, the screws in the angulation area were not checked.Repairs were performed on the video gastroscope.

• 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: matthew vernak ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 7400293
• MDR Text Key: 104736346
• Report Number: 9610877-2018-00072
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K962897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2018,03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2018
• Distributor Facility Aware Date: 03/12/2018
• Date Report to Manufacturer: 04/05/2018
• Initial Date Manufacturer Received: 03/12/2018
• Initial Date FDA Received: 04/05/2018
• 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