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

Model Number EG-2990I

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This mdr was initiated as part of a retrospective assessment of complaints/events in the us.As part of this assessment, pentax medical evaluated all us events/complaints received for currently marketed bronchoscopes, colonoscopes, and gastroscopes.The results of this retrospective assessment prompted pentax medical to file this report.

Event Description

Pentax medical became aware of a report stating the water deflector tip came loose and is missing at the conclusion of a case involving pentax model eg-2990i/serial (b)(4).No information was received from the customer regarding any adverse impact on the patient.The device involved in the event was forwarded to pentax for evaluation.Incoming inspection detected a hole in # 2 remote control button cover.No defects were noted on the distal body.Since the nozzle was not returned, an evaluation on the nozzle could not be conducted to determine its condition or root cause of the event.Repairs were performed on the video gastroscope which was successively shipped to the customer.Based on the information received from the complainant and the pentax inspectional findings, pentax determined the cause or most probable cause of the event to include, but not limited to, the following: not enough glue/adhesive on the nozzle.During reprocessing, cleaning in and around the nozzle may have caused the glue/adhesive to become weak.During the cleaning process, excessive pressure of air or water forced down the channels could cause the tightness integrity of the nozzle to the distal body to become weak and fall off during use when air/water was needed.A device history review was performed on 03/31/2016 confirming the video gastroscope 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 medical considers this medwatch report closed.

• 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: 5671249
• MDR Text Key: 45701595
• Report Number: 9610877-2016-00047
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2016,07/10/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG-2990I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2012
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/20/2016
• Distributor Facility Aware Date: 07/10/2012
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/20/2016
• Date Manufacturer Received: 07/10/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2007
• 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